Results for Tablets

URGESIN (Solifenacin Succinate)

20:28

URGESIN (Solifenacin Succinate)

URGESIN (Solifenacin Succinate)

Generic
Solifenacin Succinate

Therapeutic Class:
Urinary Incontinence Prd

Composition:
Each Urgesin tab contains 5 mg or 10 mg of solifenacin succinate.

Description:
Urgesin (Solifenacin) is used to treat contraction of overactive bladder with associated problems such as increased urination frequency and urge incontinence.

Indications:
Urgesin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

Dosage:
The recommended dose of Urgesin is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.

Presentations:
Urgesin 5 mg tab is available in pack of 10’s.Urgesin 10 mg Tab is available in pack of 10’s.
URGESIN (Solifenacin Succinate) URGESIN (Solifenacin Succinate) Reviewed by Athar on 20:28 Rating: 5

MECOVATE (Mecobalamin)

21:55

              MECOVATE (Mecobalamin)

MECOVATE (Mecobalamin)


Generic:
Mecobalamin

Therapeutic Class:
 Vitamin B12 Plain  
Composition:
 Each Mecovate tablet contains 500 µg of mecobalamin.Each Mecovate ampoule (1 ml) contains 500 µg of mecobalamin.  

Description:
Mecovate contains mecobalamin, a vitamin B12 – coenzyme that occurs in the blood and the cerebrospinal fluid. It is taken up by nerve tissues more actively and extensively than other homologues of vitamin B12.
  
Indications:
 Peripheral neuropathiesInjection: Megaloblastic anemia due to vitamin B12 deficiency 

Dosage:
Mecovate Tablet:
Adults:The usual daily dose is 3 tablets, equivalent to a total of 1500 µg of mecobalamin, administered orally in 3 divided doses.

Mecovate Injection:
Peripheral Neuropathies: The usual adult dosage is 1 amp, equivalent to 500 µg of mecobalamin administered IM or IV 3 times a week. The dosage should be adjusted according to age of patient and severity of symptoms.

Megaloblastic Anemia:The usual adult dosage is 1 amp, equivalent to 500 µg of mecobalamin administered IM or IV 3 times a week. After approximately 2 months of medication, the dose should be reduced to a single administration of 1 amp at 1- to 3-month intervals for maintenance therapy.
  
Presentations:
 Mecovate Tab 500 µg is available in pack of 100’s.Mecovate amp 500 µg is available in pack of 10’s.
MECOVATE (Mecobalamin) MECOVATE (Mecobalamin) Reviewed by Athar on 21:55 Rating: 5

PHYLLOCONTIN (225 MG)

23:45

PHYLLOCONTIN (225 MG) 

PHYLLOCONTIN (225 MG)


Generic:
Aminophylline Hydrate

Therapeutic Class:
 Xanthines – Systemic  
Composition:

Each Phyllocontin continus tablet contains aminophylline hydrate 225 mg.
  
Description:

Phyllocontin continus tablet contains aminophylline that is the salt of theophylline most commonly used for therapeutic purposes. It acts as a bronchodilator (dilates the bronchi i.e. air passage). It improves breathing by opening air passages in the lungs.
  
Indications:
 Treatment and prophylaxis of bronchospasm associated with asthma. emphysema & chronic bronchitisPrevention of
exercise-induced bronchoconstriction  
Dosage:

1-2 tablets 12 hourly ensure 24 hours protection
  
Presentations:

225 mg tabs 50’s
PHYLLOCONTIN (225 MG) PHYLLOCONTIN (225 MG) Reviewed by Athar on 23:45 Rating: 5

CHYMORAL FORTE TABLET

09:28
              CHYMORAL FORTE TABLET
                        (Trypsin, Chymotrypsin)

CHYMORAL FORTE TABLET
Generic:
Trypsin, Chymotrypsin

Therapeutic Class:
Anti-inflammatory enzyme

Composition:
Each enteric-coated tablet of Chymoral Fort contains trypsin and chymo-trypsin in ratio of approximately 6 to 1 and provides enzyme activity equivalent to 100,000 units.

Description:
Chymoral Forte contains proteolytic anti-inflammatory enzymes, which is used to resolve inflammation, reduce oedema and hasten healing of wound. The pain producedby inflammation is reduced as the inflammation subsides.After trauma andmuscle and soft tissue injury Chymoral Forte reduces the recovery time and reduces pain early in the healing phase.

Indications:
Pelvic inflammatory diseasesSprainsFracturesAccidental injuries 
Dosage:
1 Tablet 3 times daily.

Presentations:
Tabs 20’s
CHYMORAL FORTE TABLET CHYMORAL FORTE TABLET Reviewed by Athar on 09:28 Rating: 5

Zerifax (Rifaximin) 200mg/550mg

20:29

         Zerifax (Rifaximin) 200mg/550mg


Zerifax (Rifaximin) 200mg/550mg

Zerifax


Generic:
Rifaximin

Therapeutic Class:
Anti-Infective Antidiarrheal

Composition:
Each Zerifax tablet contains 200 mg or 550 mg of rifaximin

Description:
Zerifax tablet contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin. Rifaximin is a structural analog of rifampin

Indications:
Travelers’ Diarrhea:
ZERIFAX 200 mg is indicated for the treatment of patients (≥ 12 years of age) with travelers’ diarrhea caused by noninvasive strains of Escherichia coli.
Limitations of Use: ZERIFAX should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other  han Escherichiacoli.
Irritable Bowel Syndrome with Diarrhea:ZERIFAX is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Hepatic Encephalopathy: Zerifax 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age. 

Dosage:
Dosage for Travelers’ Diarrhea:
The recommended dose of ZERIFAX is one 200 mg tablet taken orally three times a day for 3 days. ZERIFAX can be administered orally, with or without food.
Dosage for Irritable Bowel Syndrome with Diarrhea: The recommended dose of ZERIFAX is one 550 mg tablet taken orally three times a day for 14 days. Patients who experience a recurrence of symptoms can be retreated up to two times with the same dosage regimen.
Dosage for Hepatic Encephalopathy: The recommended dose of Zerifax is one 550 mg tablet taken orally two times a day, with or without food.

Presentations:
Zerifax Tab 200 mg is available in pack of 10’s.Zerifax Tab 550 mg is available in pack of 10’s.

Zerifax (Rifaximin) 200mg/550mg Zerifax (Rifaximin) 200mg/550mg Reviewed by Athar on 20:29 Rating: 5

FEBUXIN (Febuxostat)

10:11

                     FEBUXIN (Febuxostat)


FEBUXIN (Febuxostat)


Generic:
Febuxostat

Therapeutic Class:
Anti-Gout

Composition:
Each Febuxin tablet contains 40 or 80 mg of febuxostat for oral administration.

Description:
Febuxin (febuxostat) is a xanthine oxidase inhibitor.

Indications:
Febuxin is indicated for the chronic management of hyperuricemia in patients with gout.

Dosage:
For treatment of hyperuricemia in patients with gout, Febuxin is recommended at 40 mg or 80 mg once daily. It can be taken without regard to food or antacid use.
The recommended starting dose of Febuxin is 40 mg once daily. For patients
who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2
weeks with 40 mg, FEBUXIN 80 mg is recommended.

Presentations:
Febuxin tab 40 mg and 80 mg is available in blister pack of 20’s.
FEBUXIN (Febuxostat) FEBUXIN (Febuxostat) Reviewed by Athar on 10:11 Rating: 5

Xiga Tablet

09:52

Xiga 5mg / 10mg
(DAPAGLIFLOZIN)




COMPOSITION:
Xiga Tablet 5mg:
Each film coated tablet contains:
Dapagliflozin propanediol monohydrate (Manufacturer’s Specs.) equivalent to
Dapagliflozin ……........................................................…… 5 mg.
(Innovator’s Specifications)
Xiga Tablet 10mg:
Each film coated tablet contains:
Dapagliflozin propanediol monohydrate (Manufacturer’s Specs.) equivalent to
Dapagliflozin ……......................................................…… 10 mg.
(Innovator’s Specifications)
DESCRIPTION:
Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4 ethoxyphenyl) methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6 •C3H8O2 •H2O and the molecular weight is 502.98.

CLINICAL PHARMACOLOGY:
Mechanism of Action:
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose
excretion.
Pharmacokinetics:
Absorption:
Following oral administration of dapagliflozin, the maximum plasma concentration (Cmax) is usually attained within 2 hours under fasting state. The Cmax and AUC values increase dose proportionally with increase in dapagliflozin dose in the therapeutic dose range. The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%. Administration of dapagliflozin with a high-fat meal decreases its Cmax by up to 50% and prolongs Tmax by approximately 1 hour, but does not alter AUC as compared with the fasted
state.These changes 
are not considered to be clinically meaningful and dapagliflozin can be administered with or without food.

Distribution:
Dapagliflozin is approximately 91% protein bound. Protein binding is not altered in patients with renal or hepatic impairment.

Metabolism:
The metabolism of dapagliflozin is primarily mediated by UGT1A9; CYP
mediated metabolism is a minor clearance pathway in humans. Dapagliflozin is extensively metabolized, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite. Dapagliflozin 3-O glucuronide accounted for 61% of a 50 mg [14C]-dapagliflozin dose and is the predominant drug-related component in human plasma.

Elimination:
Dapagliflozin and related metabolites are primarily eliminated via the renal pathway. Following a single 50 mg dose of [14C]-dapagliflozin, 75% and 21% total radioactivity is excreted in urine and feces, respectively. In urine, less than 2% of the dose is excreted as parent drug. In feces, approximately 15% of the dose is excreted as parent drug. The mean plasma terminal half-life (t½) for dapagliflozin is approximately 12.9 hours following a single oral dose of 10 mg.
Pharmacokinetics in special populations:
Renal Impairment:
The steady-state 24-hour urinary glucose excretion in patients with type 2 diabetes and mild, moderate, and severe renal impairment was 42%, 80%, and 90% lower, respectively, than patients with type 2 diabetes with normal renal function. The impact of hemodialysis on dapagliflozin exposure is not known.

Hepatic Impairment:
In patients with severe hepatic impairment (Child-Pugh class C), mean Cmax and AUC of dapagliflozin were up to 40% and 67% higher, respectively, as compared to healthy matched control.
Effects of Age, Gender, Race, and Body Weight on Pharmacokinetics:
Based on a population pharmacokinetic analysis, age, gender, race, and body weight do not have a clinically meaningful effect on the pharmacokinetics of dapagliflozin and thus, no dose adjustment is
recommended.

Pediatric:
Pharmacokinetics in the pediatric population is not known.
INDICATIONS AND USAGE:
XIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Limitation of Use:
XIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

DOSAGE AND ADMINISTRATION:
Administration
The recommended starting dose of XIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating XIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of XIGA is recommended.

DOSE MODIFICATION
RECOMMENDATIONS:
Patients with Renal Impairment:
• Assessment of renal function is recommended prior to initiation of XIGA therapy and periodically thereafter. 
• XIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2.
• No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 
 mL/min/1.73 m2 or greater).
• XIGA should be discontinued when eGFR    is persistently less than 60 mL/min/1.73 m2.
CONTRAINDICATIONS:
• History of a serious hypersensitivity
reaction to XIGA.
• Severe renal impairment, end-stage renal  disease (ESRD), or patients on dialysis.

WARNINGS AND PRECAUTIONS:
Hypotension:
XIGA causes intravascular volume contraction. Symptomatic hypotension can occur after initiating XIGA particularly in patients with impaired renal function (eGFR less than 60 
mL/min/1.73 m2), elderly patients, or patients on loop diuretics. Before initiating XIGA in patients, volume status should be assessed and corrected. Monitor for signs and symptoms of hypotension after initiating therapy.

Impairment in Renal Function:
XIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating XIGA. Renal function should be evaluated prior to initiation of XIGA and monitored periodically thereafter.


Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:
Insulin and insulin secretagogues are known to cause hypoglycemia. XIGA can increase the risk of
hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of
insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when these
agents are used in combination with XIGA.
Genital Mycotic Infections:
XIGA increases the risk of genital mycotic infections. Patients with a history of genital mycotic
infections were more likely to develop genital mycotic infections.
Increases in Low-Density Lipoprotein Cholesterol (LDL-C):
Increases in LDL-C occur with XIGA. Monitor LDL-C and treat per standard of care after initiating
XIGA.
Bladder Cancer:
XIGA should not be used in patients with active bladder cancer. In patients with prior history of bladder cancer, the benefits of glycemic control versus unknown risks for cancer recurrence with
XIGA should be considered.

Macrovascular Outcomes:
Conclusive evidences of macrovascular risk reduction with XIGA or any other antidiabetic drug are insufficient.
DRUG INTERACTIONS:
Positive Urine Glucose Test:
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay:
Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5 AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

USE IN SPECIFIC POPULATION:
Pregnancy:
Pregnancy Category C:
During pregnancy, consider appropriate alternative therapies, especially during the second and third trimesters. XIGA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:
It is not known whether XIGA is excreted in human milk, but because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from XIGA, a decision should be made whether to discontinue nursing or to discontinue XIGA, taking into account the importance of the drug to the mother.
Pediatric Use:
Safety and effectiveness of Dapagliflozin in pediatric patients under 18 years of age have not been established.
Renal Impairment:
Based on its mechanism of action, XIGA is not expected to be effective in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or ESRD.
Hepatic Impairment:
The benefit-risk for the use of dapagliflozin in patients with severe hepatic impairment should be individually assessed since the safety and efficacy of dapagliflozin have not been known in this population.
ADVERSE REACTIONS:
Specific:
Hypotension, Impairment in Renal Function, Hypoglycemia with Concomitant Use with Insulin and
Insulin Secretagogues, Genital Mycotic Infections, Increases in Low-Density Lipoprotein
Cholesterol (LDL-C), Bladder Cancer.

Allergic Reaction:
Hypersensitivity reactions (e.g., angioedema, urticaria, hypersensitivity) serious anaphylactic reactions and severe cutaneous adverse reactions and angioedema were reported at 0.2% Dapagliflozin-treated patients. If hypersensitivity reactions occur, discontinue use of XIGA; treat
per standard of care and monitor until signs and symptoms resolve.

Laboratory Tests:
Increase in Hematocrit, Increase in Serum Inorganic Phosphorus, Increase in Low-Density Lipoprotein Cholesterol.

OVERDOSAGE:
In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ supportive measures, as dictated by the patient’s clinical status.

INSTRUCTIONS:
- Store below 30ºC.
- Protect from heat, sunlight & moisture.
- Keep out of the reach of children.
- To be sold on the prescription of a registered medical practitioner only.

PRESENTATION:
Xiga Tablet 5 mg : Pack of 2x7 tablets.

Xiga Tablet 10 mg : Pack of 2x7 tablets.
Xiga Tablet Xiga Tablet Reviewed by Athar on 09:52 Rating: 5

Relaxin Tablets

05:54

                           Relaxin 3 mg

Relaxin Tablets


COMPOSITION
each tablet contains:
Bromazepam.........................3 mg

CHEMISTRY
Chemical name of Relaxin is 7-bromo-1, 3-dihydro-5(2-pyridyl)-2H-1,4-benzodiazepin-2-one(bromazepan) and its structural formula is shown below.

INTRODUCTION
Relaxin is a pyridybenzodiazopine derivativ as a potent psychotronic agent. It selectively reduces tension and anxiety where as in high doesage it shown sedative and muscle relaxing properties.

INDICATIONS
Relaxin is indicated for the short term treatment of tension, anxiety, emotional disturbances, agitation and insomia, anxious agitated depressive reactions. Functional disturbances in the cardio vascular and respiratory systems (pseudoangina pectoris precordial anxiety techycardia, emotiogenic hypertension, dyspnea; hyperventilation, psychosomatic disorders, psychogenic, heaache, psychogenic dematosis and asthma.)

CNTRAINDICATIONS
patients with known sensitivity to bonzodiazepines, acute pulmonary in sufficiency, respiratory depression, myastheina gravis. Bromazepam shod be avoided during pregnancy. The administration of high doses or porlonged administration of low doses of bonzodiazepines in the last trimester of pregnancy or during labour has been reported to produce irregularities in the foetal heart reate and hypotonia, poor sucking and hypothermia in the neonates.

DOSAGE AND ADMINISTRATION
Adults: The optimum dosage and frequency of administration of Relaxin should be based on the individual patient, the severity of symptom and previous psychotropic drug history.

The usual dosage in general practice is from half to one tablet three times daily. In severe cases especially in hospitalized patients two to four tablets tow to three daily. In exceptional circumstances upto the maximum daily dosage of 60 mg in dividad doses, may be given.

After about three to six week, according to progreess in therapy, dosege can ususally gradually be redued and then stopped.

Children: Relaxin is not for paediatric use.

PRESENTATION
tablets: 3 x 10 Blister pack

Relaxin Tablets Relaxin Tablets Reviewed by Athar on 05:54 Rating: 5

Nuberol Forte Tablets (paracetamol BP 650 mg + Orphenadrine Citrate BP 50 mg)

01:48

Nuberol Forte Tablets (paracetamol BP 650 mg + Orphenadrine Citrate BP 50 mg)

Nuberol Forte Tablets

(paracetamol BP 650 mg + Orphenadrine Citrate BP 50 mg)

BRIEF PRESCPIBUNG INFORMATION

PROPERTIES
Nuberol is a muscle relaxant with analgesic.

PRESENTATION AND COMPOSITION
Nuberol is white round shaped, engraved 'SEARLE' on one side each tablet contains Paracetamol BP 450mg and Orphenadrine Citrate BP 35mg.

Nuberol Forte is white, oblong scored tablets stamped stamped searle on one side each containing Paracetamol BP 650mg and Orphenadrine Citrate BP 50mg.

Pharmacology:
The combined analgesic effect of Paracetamol and muscle relaxant action of Orphenadrine Citrate provides in-depth relief from pain associated with skeletal muscle spasm.

Paracetamol possess analgesic and antipyrrtic action similar to those of the salicylates.

Analgesia is mediated peripherally and also centrally.

Paracetamol is a synthetic derivative of p-aminophenol with analgesic and antipyretic activity but on anti-inflammatory action. Its plasma half-life is about 2 hours. It is extensively metabolized in the liver and subsequently excreted in the urine.

Orphenadrine Citrate is an orally effective muscle relaxan. The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions. Muscle relaxation is not due to a direct action on the muscle itself; rather the site of ection of Orphenadrine citrate is contral. Orphenadrine is readily absorbed from the gastro-intesinal tract and is almost completely metabolized to at least 8 metablites.

It is mainly excreted in the urine as metabolised and unchanged drug.

Indications:
For the relief of painful skeletal muscle spasm associated with chronic low back pain, spranins, strains, prolapsed intervertebbral disc, muscle injury, non-articular rheumatism, and tension headache, dysmenorrheal and other acute or chronic painful muscular conditions.

Contraindication:

Paracetamol:
Hypersensitivy to paracetamol, Repeated administration is contraindicated in patients with hepatic insufficientcy.

Orphenadrine citrate:
It is contraindicated in patients hypersensitive to Orphenadrine citrate. Orphenadrine should not be given to patientsvof myasthenia gravis, glaucona, urinary retention or lactating woman.

Dosage and Administration:

Nuberol:    Adults   : 1-2 tablet 3-4 times/day
                   Children : Not recommended.

Nuberol Fort:  Adults  : 1 tablet twice daily
                        Children : Not recommended.

Overdosage:

In overdosage Paracetamol is dangerously hepatotoxic; potentially falal hepatic necrosis can occur after ingestion of as little as a single dose of 10-15 g. Signs of mild gastrointestinal irritation are commonly followed 2 day later by anorexia, nausea, malaise, abdominal pain, progressive evidence of liver failure and, ultimately, hepatic come. Either methionone or ecetylcysteine may be used as a specific antidote. Fluid and electrolyte balance must be maintained and ventilation must be assisted when respiration is depressed.

Orphenadrine is toxic when overdosed and typically induces Anti-cholinergic effects.
Nuberol Forte Tablets (paracetamol BP 650 mg + Orphenadrine Citrate BP 50 mg) Nuberol Forte Tablets (paracetamol BP 650 mg + Orphenadrine Citrate BP 50 mg) Reviewed by Athar on 01:48 Rating: 5

Panadol Cold and Flu 500 mg / 30 mg Film Coated Tablets

08:13
Panadol Cold and Flu 500 mg / 30 mg Film Coated Tablets

Panadol Cold and Flu 500 mg / 30 mg Film Coated Tablets

Paracetamol and Pseudoephedrine Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
 You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
What is in this leaflet:
1. What Panadol Cold and Flu is and what it is used for
2. What you need to know before you take Panadol Cold and Flu
3. How to take Panadol Cold and Flu
4. Possible side effects
5. How to store Panadol Cold and Flu
6. Contents of the pack and other information
1. What Panadol Cold and Flu is and what it is used for
Panadol Cold and Flu is used for the relief of nasal congestion when combined with fever and/or
pain such as sore throat, sinus pain or headache in the common cold or flu. The medicine
contains two active ingredients. Paracetamol is a painkiller and reduces your temperature when
you have a fever. Pseudoephedrine hydrochloride is a decongestant which unblocks your nose
and sinuses helping you breathe more easily without drowsiness.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
2. What you need to know before you take Panadol Cold and Flu
Do not take Panadol Cold and Flu:
 If you are allergic to paracetamol, pseudoephedrine hydrochloride or other
sympathomimetics (such as decongestants, appetite suppressants or stimulant drugs
called amphetamines), or any of the other ingredients (listed in section 6).
 If you have high blood pressure, overactive thyroid gland, enlarged prostate, heart
problems, glaucoma (excessive pressure inside your eyes).
 If you have kidney problems, unless your doctor tells you to.
 If you have taken monoamine oxidase inhibitors (MAOIs), usually prescribed for
depression, in the last two weeks.
 If you are taking the drug moclobemide for depression, beta-blockers for high blood
pressure, the antibiotics furazolidone or linezolid, appetite suppressants, or stimulant
drugs called amphetamines (sometimes used to treat attention deficit disorders or
excessive sleepiness).
 For more than 5 days unless your doctor tells you to.
If you are under 12 years.
Do not takeanything else containing paracetamol while taking this medicine.
Do not take with any other flu, cold or decongestant product.
Warnings and precautions
Talk to your doctor or pharmacist before taking Panadol Cold and Flu:
If you are due to undergo general anaesthesia, or have liver disease, including alcoholic liver
disease, diabetes, irregular heart beat or phaeochromocytoma (a tumour near the kidney).
Other medicines and Panadol Cold and Flu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines particularly:
 anticoagulants (used to thin the blood, e.g. warfarin);
 metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]);
 cholestyramine (to lower blood cholesterol);
 medicines for high blood pressure;
 medicines for depression (tricyclic antidepressants e.g. amitriptyline);
 sodium bicarbonate (used to treat indigestion and certain kidney conditions).
Pregnancy and breastfeeding
Do not take Panadol Cold and Flu if you are pregnant or breastfeeding.
Driving and using machines
This product can cause dizziness as a side effect which could affect your ability to drive or use
machines. Do not drive or operate machinery if affected.
3. How to take Panadol Cold and Flu
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Take the tablets with a glass of water.
The recommended dose is:
Adults (including the elderly):
Swallow 2 tablets up to 3 times daily, every 4 hours as needed.
Do not take more than 6 tablets (3 doses) in 24 hours.
Adolescents aged 12 to 18 years:
Give 1 to 2 tablets every 4 hours as needed.
Do not give more than 6 tablets in 24 hours.
Do not take more frequently than every 4 hours.
Do not take for more than 5 days.
Do not take more than the recommended dose.
If you take more Panadol Cold and Flu than you should
, Talk to your doctor at once if you take too much of this medicine, even if you feel well. This is
because too much paracetamol can cause delayed, serious liver damage.
If your symptoms persist, see your doctor or pharmacist.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Panadol Cold and Flu can cause side effects, although not everybody gets
them:
Stop taking this medicine and seek immediate medical attention if you experience:
 Sudden severe headache.
 Sudden abdominal pain or blood in your stools.
 Breathing problems, especially if you have experienced a similar reaction with aspirin or
non-steroidal anti-inflammatories.
 Skin rash or peeling, or mouth ulcers.
 Unexplained bruising or bleeding, or infections such as sore throat - this may be a sign of
very rare changes in the blood.
 Allergic reactions such as skin rash or itching, sometimes with breathing problems (or a
hissing sound when you breathe) or swelling of the lips, tongue, throat or face.
 Difficulty in passing urine. This is more likely to occur if you have an enlarged prostate
gland.
Other side effects
The following side effects may occur. Tell your doctor or pharmacist if you get them.
 Nausea [feeling sick], vomiting [being sick], dry mouth, sleep disturbance, nervousness
and dizziness. These are common side effects, (may affect up to 1 in every 10 patients
treated).
 Rapid or irregular heart rate, agitation and restlessness. These are uncommon side effects
(may affect up to1 in every 100 patients treated).
 High blood pressure and hallucinations are rare side effects (may affect up to 1 in
every 1,000 patients treated).
 This product may have side effects that you would not notice yourself. These include
changes in some liver test results.
Reporting side effects
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Panadol Cold and Flu
Keep this medicine out of the sight and reach of children.
Do not take the medicine after the “EXP” shown on the blister and outer carton. The expiry date
refers to the last day of that month.
Do not use the medicine if you notice the tablets are soft.
Do not store above 25ºC.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Panadol Cold and Flu contains:
- The active ingredients are Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg .
- The other ingredients are cellulose microcrystalline (E460), silica, colloidal anhydrous
(E551), stearic acid (E570), magnesium stearate (E572), starch pregelatinised, povidone,
crospovidone, croscarmellose sodium (E468), hypromellose (E464), macrogol, carnuba
wax (E903), indigo carmine (E132).
What Panadol Cold and Flu looks like and contents of the pack
The tablets are blue and white and marked with a figure “2” in a circle.
Packs contain 2, 5, 6, 10, 12, 16, 18, 24, 30 or 32 tablets.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.
The manufacturer is Famar S.A., Anthoussa, Athens, Greece.
This leaflet was last revised in July, 2016
Panadol is a registered trademark owned by or licensed to the GSK group of companies.
Panadol Cold and Flu 500 mg / 30 mg Film Coated Tablets Panadol Cold and Flu 500 mg / 30 mg Film Coated Tablets Reviewed by Athar on 08:13 Rating: 5

TENORMIN (atenolol)

08:41
TENORMIN
(atenolol)
Tablets, 50 mg and 100 mg

TENORMIN (atenolol)

THERAPEUTIC CLASSIFICATION
Beta-adrenergic receptor blocking agent
ACTIONS AND CLINICAL PHARMACOLOGY
TENORMIN (atenolol) is a beta1-selective, beta adrenergic blocking agent, devoid of
membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities. It is a racemic
mixture and the beta1 properties reside in the S(-) enantiomer. Beta1-selectivity decreases
with increasing dose.
The mechanism of the antihypertensive effect has not been established. Among the factors
that may be involved are:
(a) competitive ability to antagonize catecholamine-induced tachycardia at the beta-
receptor sites in the heart, thus decreasing cardiac output
(b) inhibition of renin release by the kidneys
(c) inhibition of the vasomotor centres
The mechanism of the anti-anginal effect is also uncertain. An important factor may be the
reduction of myocardial oxygen requirements by blocking catecholamine-induced increases in
heart rate, systolic blood pressure, and the velocity and extent of myocardial contraction.
In man atenolol reduces both isoproterenol- and exercise-induced increases in heart rate over
the dose range of 50 to 200 mg. At an oral dose of 100 mg the beta1 blocking effects persist
for at least 24 hours; the reduction in exercise-induced heart rate increase being about 32%
and 13%, 2 and 24 hours after dosing, respectively. The logarithm of the plasma atenolol
level correlates with the degree of beta1 blockade but not with the antihypertensive effect.

Pharmacokinetics

Approximately 40 to 50% of an oral dose of atenolol is absorbed from the gastrointestinal
tract, the remainder being excreted unchanged in the feces. Peak plasma concentrations occur
2-4 hours after dosing and are subject to a 4-fold variability. The plasma levels are
proportional to dose over the range 50-400 mg and 6 to 16% of atenolol is bound to plasma
proteins. The mean peak plasma concentrations of atenolol were approximately 300 and 700
nanogram/mL following 50 and 100 mg, respectively. The plasma half-life is approximately
6-7 hours. Atenolol is extensively distributed to extravascular tissues, but only a small
amount is found in the central nervous system.
There is no significant hepatic metabolism of atenolol in man and more than 90% of the
absorbed dose reaches the systemic circulation unaltered. Small quantities of a hydroxy
metabolite and a glucuronide are produced but neither has major pharmacological activity. As
a consequence no accumulation occurs in patients with liver disease and no dosage adjustment
is required. Approximately 47 and 53% of the oral dose is eliminated in the urine and feces,
respectively. Recovery is complete after 72 hours.
Atenolol is primarily eliminated by the kidney, predominantly by glomerular filtration. The
normal elimination half-life may increase in severe renal impairment but no significant
accumulation occurs in patients who have creatinine clearance greater than 35 mL/min. The
oral dose should be reduced in patients with a creatinine clearance less than 35 mL/min (see
DOSAGE and ADMINISTRATION).
Following intravenous administration, peak plasma levels were reached within 5 minutes.
Declines from peak plasma levels are rapid (5- to 10-fold) during the first 7 hours; thereafter,
plasma levels decay with a half-life similar to that of orally administered drug. Over 85% of
an intravenous dose is excreted in urine within 24 hours.
Atenolol is excreted in human breast milk and crosses the placental barrier - the maternal to
cord blood ratio being about unity.

INDICATIONS AND CLINICAL USE
Hypertension
TENORMIN (atenolol) tablets are indicated in patients with mild or moderate hypertension.
It is usually used in combination with other drugs, particularly a thiazide diuretic. However, it
may be tried alone as an initial agent in those patients in whom, in the judgement of the
physician, treatment should be started with a beta-blocker rather than a diuretic. TENORMIN
may be used in combination with diuretics and/or vasodilators to treat severe hypertension.
The combination of TENORMIN with a diuretic or peripheral vasodilator has been found to
be compatible. Limited experience with other antihypertensive agents has not shown evidence
of incompatibility with TENORMIN.

TENORMIN is not recommended for the emergency treatment of hypertensive crises.

Angina Pectoris
TENORMIN tablets are indicated in the long-term management of patients with angina
pectoris due to ischemic heart disease.
CONTRAINDICATIONS
TENORMIN (atenolol) should not be used in the presence of:
1. sinus bradycardia, or bradycardia of other origin
2. second and third degree A-V block
3. sick sinus syndrome
4. right ventricular failure secondary to pulmonary hypertension
5. uncontrolled heart failure
6. cardiogenic shock
7. hypotension
8. severe peripheral arterial disorders
9. anesthesia with agents that produce myocardial depression
10. pheochromocytoma, in the absence of alpha-blockade
11. metabolic acidosis
12. known hypersensitivity to the product
WARNINGS
a) Cardiac Failure
Special caution should be exercised when administering TENORMIN (atenolol) to patients
with a history of heart failure. Sympathetic stimulation is a vital component supporting
circulatory function in congestive heart failure and inhibition with beta blockade always
carries the potential hazard of further depressing myocardial contractility and precipitating
cardiac failure. TENORMIN acts selectively without abolishing the inotropic action of
digitalis on the heart muscle. However, the positive inotropic action of digitalis may be
reduced by the negative inotropic effect of TENORMIN when the two drugs are used
concomitantly. The effects of beta-blockers and digitalis are additive in depressing A-V
conduction. In patients without a history of cardiac failure, continued depression of the
myocardium over a period of time can, in some cases, lead to cardiac failure. Therefore, at the
first sign or symptom of impending cardiac failure, patients should be fully digitalised and/or
given a diuretic and the response observed closely. If cardiac failure continues, despite
adequate digitalisation and diuretic therapy, TENORMIN therapy should be immediately
withdrawn.
b) Abrupt Cessation of Therapy with TENORMIN
Patients with angina should be warned against abrupt discontinuation of TENORMIN. There
have been reports of severe exacerbation of angina and of myocardial infarction or ventricular
arrhythmias occurring in patients with angina pectoris, following abrupt discontinuation of
beta-blocker therapy. The last two complications may occur with or without preceding
exacerbation of angina pectoris. Therefore, when discontinuation of TENORMIN is planned
in patients with angina pectoris, the dosage should be gradually reduced over a period of about
two weeks and the patient should be carefully observed and advised to limit physical activity
to a minimum. The same frequency of administration should be maintained. In situations of
greater urgency, TENORMIN should be discontinued stepwise over a shorter time and under
closer observation. If angina markedly worsens or acute coronary insufficiency develops, it is
recommended that treatment with TENORMIN be reinstituted promptly, at least temporarily.
c) Oculomucocutaneous Syndrome
Various skin rashes and conjunctival xerosis have been reported with beta-blockers, including
TENORMIN. A severe syndrome (oculomucocutaneous syndrome) whose signs include
conjunctivitis sicca and psoriasiform rashes, otitis, and sclerosing serositis has occurred with
the chronic use of one beta-adrenergic blocking agent (practolol). This syndrome has not been
observed with TENORMIN or any other such agent. However, physicians should be alert to
the possibility of such reactions and should discontinue treatment in the event that they occur.
d) Prinzmetal's Angina
TENORMIN may increase the number and duration of angina attacks in patients with
Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery
vasoconstriction. TENORMIN, therefore, should only be used in these patients with the
utmost care.
e) Sinus Bradycardia
Severe sinus bradycardia may occur with the use of TENORMIN from unopposed vagal
activity remaining after blockade of beta1-adrenergic receptors; in such cases, dosage should
be reduced.
f) Thyrotoxicosis
In patients with thyrotoxicosis, possible deleterious effects from long-term use of
TENORMIN have not been adequately appraised. Beta-blockade may mask the clinical signs
of continuing hyperthyroidism or its complications and give a false impression of
improvement. Therefore, abrupt withdrawal of TENORMIN may be followed by an
exacerbation of the symptoms of hyperthyroidism, including thyroid storm.
g) Pregnancy
Atenolol can cause fetal harm when administered to a pregnant woman. Atenolol crosses the
placental barrier and appears in the cord blood.
No studies have been performed on the use of atenolol in the first trimester and the possibility
of fetal injury cannot be excluded. Administration of atenolol, starting in the second trimester
of pregnancy, has been associated with the birth of infants that are small for gestational age.
Studies in humans have shown that transplacental passage of atenolol does occur in pregnant
women, with fetal drug serum levels equal to those of the mother. In a limited number of
patients who were given the drug during the last trimester of pregnancy, low birth weight,
neonatal hypoglycemia, bradycardia in the fetus/newborn, and placental insufficiency were
observed.
Neonates born to mothers who are receiving TENORMIN at parturition or breast-feeding may
be at risk for hypoglycemia and bradycardia. Caution should be exercised when TENORMIN
is administered during pregnancy or to a woman who is breast-feeding. (See
PRECAUTIONS, Use in Lactating Women.)
Atenolol has been shown to produce a dose-related increase in embryo/fetal resorptions in rats
at doses equal to or greater than 50 mg/kg/day or 25 or more times the maximum
recommended human dose.
PRECAUTIONS
a) Bronchospastic Disorders
Patients with bronchospastic diseases should, in general, not receive beta-blockers. Due to the
relative beta1-selectivity of TENORMIN, TENORMIN may be used with caution in patients
with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive
treatment. Since beta1-selectivity is not absolute, a beta2-stimulating agent should be
administered concomitantly, the lowest possible dose of TENORMIN should be used.
Despite these precautions, the respiratory status of some patients may worsen, and, in such
cases, TENORMIN should be withdrawn.
b) First Degree Heart Block
Due to its negative effect on A-V conduction time, TENORMIN should be used with caution
in patients with first degree block.
c) Peripheral Arterial Circulatory Disorders
TENORMIN may aggravate less severe peripheral arterial circulatory disorders (see
CONTRAINDICATIONS).
d) Anaphylaxis - Epinephrine and Beta-Blockers
There may be increased difficulty in treating an allergic type reaction in patients on beta
blockers. In these patients, the reaction may be more severe due to pharmacological effects of
beta-blockers and problems with fluid changes. Epinephrine should be administered with
caution since it may not have its usual effects in the treatment of anaphylaxis. On the one
hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the
other, these doses can be associated with excessive alpha adrenergic stimulation with
consequent hypertension, reflex bradycardia and heart-block and possible potentiation of
bronchospasm. Alternatives to the use of large doses of epinephrine included vigorous
supportive care such as fluids and the use of beta agonists including parenteral salbutamol or
isoproterenol to overcome bronchospasm, and norepinephrine to overcome hypotension.
e) Diabetes and Patients Subject to Hypoglycemia
TENORMIN should be administered with caution to patients subject to spontaneous
hypoglycemia, or to diabetic patients (especially those with labile diabetes) who are receiving
insulin or oral hypoglycemic agents. Beta-adrenergic blockers may mask the premonitory
signs (e.g. tachycardia) and symptoms of acute hypoglycemia.
f) Impaired Renal Function
TENORMIN should be used with caution in patients with impaired renal function (see
DOSAGE AND ADMINISTRATION).
When renal function is impaired, clearance of atenolol is closely related to the glomerular
filtration rate; however, significant accumulation does not occur until the creatinine clearance
falls below 35 mL/min/1.73 m2
.
g) Elective or Emergency Surgery
It is not advisable to withdraw beta-adrenoceptor blocking drugs prior to surgery in the
majority of patients. However, care should be taken when using TENORMIN with
anaesthetic agents such as those which may depress the myocardium. Vagal dominance, if it
occurs, may be corrected with atropine (1-2 mg i.v.).
Some patients receiving beta-adrenergic blocking agents have been subject to protracted
severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat
has also been reported.
In emergency surgery, since atenolol is a competitive inhibitor of beta-adrenergic receptor
agonists, its effects may be reversed, if necessary, by sufficient doses of such agonists as
isoproterenol or norepinephrine.
h) Ethnic Populations
TENORMIN appears to be effective and well-tolerated in most ethnic populations, although
the responses may be less in black patients than in Caucasians.
i) Use in Lactating Women
In humans, there is a significant accumulation of atenolol in the breast milk of lactating
women. Neonates born to mothers who are breastfeeding may be at risk for hypoglycemia
and bradycardia. If the use of TENORMIN is considered essential, then mothers should stop
nursing.
j) Use in Children
There is no experience with TENORMIN in the treatment of pediatric age groups.
k) Activities Requiring Mental Alertness
Use of TENORMIN is unlikely to result in any impairment of the ability of patients to drive or
operate machinery. However, it should be taken into account that dizziness or fatigue may
occur.
l) Geriatric Use
Clinical studies of TENORMIN did not include sufficient numbers of subjects aged 65 and
over to determine whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between elderly and younger
patients. In general, dose selection for an elderly patient should be cautious, usually starting
at the low end of the dosing range, reflecting the greater frequency of decreased hepatic renal,
or cardiac function, and concomitant diseases or other drug therapy.
m) Drug Interactions
Clonidine
Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of
clonidine. If the two drugs are co-administered, the beta-blocker should be withdrawn several
days before discontinuing clonidine. If replacing clonidine by beta-blocker therapy, the
introduction of beta-blockers should be delayed for several days after clonidine administration
has stopped. (Also see prescribing information for clonidine).
Reserpine or Guanethidine
Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be
closely monitored because the added beta-adrenergic blocking action of TENORMIN may
produce an excessive reduction of sympathetic activity. TENORMIN should not be combined
with other beta-blockers.
Antiarrhythmic Agents
Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating
effect on atrial-conduction time and induce negative inotropic effect.
Calcium Channel Blockers
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects
can lead to prolongation of S-A and A-V conduction, particularly in patients with impaired
ventricular function, conduction abnormalities, or diminished cardiac output. This may result
in severe hypotension, bradycardia and cardiac failure. Concomitant therapy with
dihydropyridines, e.g., nifedipine, may increase the risk of hypotension, and cardiac failure
may occur in patients with latent cardiac insufficiency.
Digitalis Glycosides
Digitalis glycosides may potentiate the bradycardia of beta1-blockade.
Non-Steroidal Anti-Inflammatory Agents
The concomitant use of non-steroidal anti-inflammatory agents may blunt the antihypertensive
effects of beta-blockers.
Anaesthetic Agents
Anaesthetics can produce a hypotensive state with associated reflex tachycardia. Since beta-
blockade will inhibit reflex tachycardia, the hypotensive potential of anaesthetic agents is
increased with concomitant use of TENORMIN. The anaesthetist should be informed and the
choice of anaesthetic should be an agent with as little negative inotropic activity as possible
(see CONTRAINDICATIONS and PRECAUTIONS, Elective or Emergency Surgery).
Fingolimod
Concomitant use of fingolimod with beta blockers may potentiate bradycardic effects and is
not recommended. Where such co-administration is considered necessary, appropriate
monitoring at treatment initiation, i.e. at least overnight monitoring, is recommended.
ADVERSE REACTIONS
The most serious adverse reactions encountered are congestive heart failure, A-V block and
bronchospasm. Bronchospasm may occur in patients with bronchial asthma or a history of
asthmatic complaints.
The most common adverse reactions reported in clinical trials with oral TENORMIN
(atenolol) in 2500 patients are bradycardia (3%), dizziness (3%), vertigo (2%), fatigue (3%),
diarrhea (2%) and nausea (3%).
Adverse reactions occuring with an incidence of less than 1%, grouped by system, are as
follows:
Cardiovascular
Heart failure deterioration (see WARNINGS)
Heart block
Palpitations
Lengthening of P-R interval
Chest pain
Lightheadedness
Postural hypotension which may be associated with syncope
Raynaud's phenomenon
Intermittent claudication, or worsening of pre-existing intermittent claudication
Leg pain and cold extremities
Edema
Respiratory
Dyspnea, wheeziness
Cough
Bronchospasm
Central Nervous System
Faintness
Ataxia
Tiredness
Lethargy
Nervousness
Depression
Drowsiness
Vivid dreams
Insomnia
Paresthesia
Headache
Tinnitus
Mood Changes
Visual disturbances
Psychoses and hallucinations
Gastrointestinal
Constipation
Anorexia
Abdominal discomfort, indigestion
Miscellaneous
Skin rash
Itchy and/or dry eyes
Psoriasiform skin reactions
Exacerbation of psoriasis
Decreased exercise tolerance
Alopecia
Epistaxis
Flushes
Impotence, decreased libido
Sweating
General body aches
Thrombocytopenia and purpura
POST MARKETING EXPERIENCE
During the post-marketing experience with TENORMIN, cold extremities, gastrointestinal
disturbances and fatigue were commonly reported. The following have been reported in
temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, headache,
confusion, nightmares, impotence, Peyronie's disease, psoriasiform rash or exacerbation of
psoriasis, purpura, reversible alopecia and thrombocytopenia. Rare cases of hepatic toxicity including intrahepatic cholestasis have been reported. TENORMIN, like other beta blockers,
has been associated with the development of antinuclear antibodies (ANA) and lupus
syndrome.
In a long-term, well-controlled trial of 1,627 elderly patients with systolic hypertension, the
incidence of dry mouth was significantly higher in patients taking atenolol (12.2%).
Potential Adverse Reactions
The following adverse reactions have occurred with other beta-blockers but have not been
reported with TENORMIN:
Cardiovascular: pulmonary edema, cardiac enlargement, hot flushes and sinus
arrest
Central Nervous System: aggressiveness, anxiety, short term memory loss, and emotional
lability with slightly clouded sensorium
Allergic: laryngospasm, status asthmaticus and fever combined with
aching and sore throat
Dermatological: exfoliative dermatitis
Ophthalmological: blurred vision, burning, and grittiness
Hematological: agranulocytosis
Gastrointestinal: mesenteric arterial thrombosis and ischemic colitis
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Limited information is available with regard to overdosage with TENORMIN (atenolol) in
humans. Overdosage with atenolol has been reported with patients surviving acute doses as
high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely.
The predominant symptoms reported following atenolol overdosage are lethargy, disorder of
respiratory drive, wheezing, sinus pause, and bradycardia. Additionally, common effects
associated with overdosage of any beta-adrenergic blocking agent are congestive heart failure,
hypotension, bronchospasm, and/or hypoglycemia.
Treatment should be symptomatic and supportive and directed to the removal of any
unabsorbed drug by induced emesis, or administration of activated charcoal. Atenolol can be
removed from the general circulation by hemodialysis. Further consideration should be given
to dehydration, electrolyte imbalance and hypotension by established procedures.

Other treatment modalities should be employed at the physician's discretion and may include:
BRADYCARDIA: Atropine 1-2 mg intravenously. If there is no
response to vagal blockade, give isoproterenol
cautiously. In refractory cases, a transvenous cardiac
pacemaker may be indicated. Glucagon in a 10 mg
intravenous bolus has been reported to be useful. If
required, this may be repeated or followed by an
intravenous infusion of glucagon 1-10 mg/h
depending on response. If no response to glucagon
occurs or if glucagon is unavailable, a beta-
adrenoceptor stimulant such as dobutamine 2.5 to 10
micrograms/kg/minute by intravenous infusion or
isoproterenol 10 to 25 micrograms given as an
infusion at a rate not exceeding 5 micrograms/minute
may be given, although larger doses may be required.
HEART BLOCK:
(second or third degree)
Isoproterenol, or transvenous pacemaker.
CONGESTIVE HEART FAILURE: Digitalize the patient and administer a diuretic.
Glucagon has been reported to be useful.
HYPOTENSION: Vasopressors such as dopamine or norepinephrine.
Monitor blood pressure continuously.
BRONCHOSPASM: A beta2-stimulant such as isoproterenol or terbutaline
and/or intravenous aminophylline.
HYPOGLYCEMIA: Intravenous glucose.
Based on the severity of symptoms, management may require intensive support care and
facilities for applying cardiac and respiratory support.
DOSAGE AND ADMINISTRATION
Hypertension
TENORMIN (atenolol) is usually used in conjunction with other antihypertensive agents,
particularly a thiazide diuretic, but may be used alone (see INDICATIONS).
The dose of TENORMIN should be administered in accordance with individual patient's
needs.
The following guidelines are recommended:
The initial dose of TENORMIN is 50 mg administered as one tablet a day either added to
diuretic therapy or alone. The full effect of this dose will usually be seen within one to two
weeks. If an adequate response is not achieved, the dose should be increased to TENORMIN
100 mg once daily. Increasing the dose beyond 100 mg a day is unlikely to produce any
further benefit.
If further lowering of the blood pressure is required, another antihypertensive agent should be
added to the regimen.
Angina Pectoris
The initial dose of TENORMIN is 50 mg given as one tablet a day. The full effect of this
dose will usually be seen within one to two weeks. If an optimal response is not achieved
within one week, the dosage should be increased to TENORMIN 100 mg given as one tablet a
day or 50 mg twice daily. Some patients may require a dosage of 200 mg a day for optimal
effect.
Patients with Renal Impairment
Since atenolol is eliminated predominantly via the kidneys, dosage should be adjusted in
patients with severe renal impairment. Significant accumulation of atenolol occurs when
creatinine clearance falls below 35 mL/min/1.73m2
(normal range is 100-150
mL/min/1.73m2
).
The following maximum dosages are recommended for patients with renal impairment:
Creatinine
Clearance(mL/min/1.73m2
)
Atenolol Elimination Half-
Life(hr)
Maximum Dosage
15-35 16-27 50 mg daily
<15 >27 50 mg every other day
Patients on hemodialysis should be given 50 mg after each dialysis; this should be done under
hospital supervision as marked falls in blood pressure can occur.
Dosage requirements may be reduced in the elderly, especially in patients with impaired renal
function.
PHARMACEUTICAL INFORMATION
Drug Substance
Proper name Atenolol
Chemical Name 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-
benzeneacetamide
Molecular Formula C14H22N2O3
Structural Formula
Molecular Weight
(free base)
266.34
Description Atenolol is a white or almost white crystalline powder. It is a
relatively polar hydrophilic compound with a water solubility of 26.5
mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23.
Atenolol is freely soluble in 1N HCl (300 mg/mL at 25°C) and less
soluble in chloroform (3 mg/mL at 25°C). The melting point for
atenolol is 152.0°C to 155.0°C
Composition
In addition to the active ingredient atenolol, each tablet contains the following inactive
ingredients: maize starch, heavy magnesium carbonate, gelatin, sodium lauryl sulphate,
magnesium stearate, hydroxypropyl methylcellulose, glycerol and titanium dioxide.
Storage Recommendations
TENORMIN Tablets should be stored between 15 and 25°C, protected from light and
moisture.
AVAILABILITY OF DOSAGE FORMS
50 mg tablets – white, round biconvex, film-coated tablets embossed with 50 on one face and
bisected on the reverse, in calendar packs of 30 tablets.
100 mg tablets – white, round biconvex, film-coated tablets embossed with 100 on one face
and bisected on the reverse, in calendar packs of 30 tablets.
PHARMACOLOGY
Animal Studies
Chronic studies performed in animals have revealed the occurrence of vacuolation of
epithelial cells of Brunner's glands in the duodenum of both male and female dogs at all tested
dose levels of atenolol (starting at 15 mg/kg/day or 7.5 times the maximum recommended
human dose) and an increased incidence of atrial degeneration of hearts of male rats at 300 but
not 150 mg atenolol/kg/day (150 and 75 times the maximum recommended human dose,
respectively).
Effect on the Cardiovascular System
In anesthetized cats, atenolol infusion reduces the chronotropic response to isoproterenol and
right cardiac sympathetic nerve stimulation.
In anesthetized dogs, atenolol 0.03 mg/kg i.v. depresses the heart rate by 22%, cardiac
contractile force by 16% and diastolic blood pressure by 11%.
Studies in rats showed that atenolol was devoid of intrinsic sympathomimetic activity.
Atenolol in concentrations up to 10 mg/mL had no local anesthetic effect on the isolated
sciatic nerve of the frog.
Atenolol (5-20 mg/kg i.v.) was without effect on the ventricular tachycardia produced by toxic
levels of ouabain in anesthetized dogs. Atenolol (0.2 mg/kg i.v.) protected coronary ligated
dogs from the arrhythmogenic activity of adrenaline on the fourth day after ligation (when the
cardiac rhythm was predominantly sinus).
Single oral doses of 100 mg atenolol given to volunteers reduced exercise-induced tachycardia
by 31% at 4 hours and by 15% at 24 hours after administration. The maximal suppression of
the systolic blood pressure response to exercise was 21% at 4 hours.
Effects on Plasma Renin Activity
Studies in hypertensive patients have shown that the antihypertensive effect of atenolol is
associated with a decrease in plasma renin activity.
Effects on Pulmonary Function
The effects of a single 100 mg dose of atenolol on forced expiratory volume (FEV1) and
airways resistance (AWR) were assessed in ten patients with labile asthma. The
cardioselective agents tested in this comparative trial, including atenolol, usually had a lesser
dose-related effect on airway function than non-selective beta-blockers. Atenolol produced a smaller decrease in FEV1 than did the non-selective agents and did not inhibit the
bronchodilator response to isoprenaline. The decrease in FEV1 was 8-9%. Other studies in
asthmatic patients have reported similar decreases in FEV1 with atenolol. Dose-effect
comparisons with cardioselective agents have shown a fall in FEV1 values at the higher doses,
indicating some beta2-blocking effect.
Metabolic Effects
TENORMIN did not potentiate the hypoglycemic effects of insulin in 12 patients with
diabetes.
TOXICOLOGY
Acute Toxicity
Species Sex Concentration Route LD50 (mg/kg)
Mouse M/F 20% (1) Oral >2000
Mouse M/F 0.8-1.2% (2) i.v. 100
Rat M/F 30% (1) Oral >3000
Rat Male 21.3% (3) Oral 4960
Rat Female 21.3% (3) Oral 6600
Rat M/F 1.0-4.0% (2) i.v. 50-60
Rat Male 0.5% (2) i.v. 129(25)
Rat Female 0.5% (2) i.v. 114(30)
Rhesus Monkey M/F Variable (1) Oral >6000
(1) Suspension (2) Solution (3) Formulated Tablet
Toxic signs in rats were: depression, ataxia, labored respiration, cyanosis, tremors and
convulsions. Effects occurred within 5 minutes following intravenous administration and
surviving rats appeared normal after 2 hours. Effects following oral administration occurred
within 1 hour and some persisted through 48 hours. Surviving rats appeared normal within 72
hours.
Following intravenous administration, all mice convulsed immediately and those animals
dying did so within 5 minutes.
Toxic signs in monkeys following oral administration were emesis, lethargy, slight mydriasis,
occasional ptosis, salivation and decreased respiration. Surviving monkeys appeared normal
within 24 hours.
TENORMIN (atenolol) TENORMIN (atenolol) Reviewed by Athar on 08:41 Rating: 5

Tonoflex-P Tablets

00:57

                                Tonoflex-P

                  (Tramadol HCI + Paracetamol)

Tonoflex-P Tablets


Composition:
Each film coated tablet contains:
Tramadol HCI Ph. Eur.......37.5mg
Paracetamol BP..... ..............32.5mg

Clinical Pharmacology:
Mode of Action
Tramadol is a centrally acting synthetic analgesic compound whose analgesic profile can be attributed to the binding of parent and 0-demethylated (M1) metabolites to opioid receptors as well as the weak inhibition of neuronal re-uptake of noradrenaline and serotonin. Paracetamol also has centrally acting analgesic effects

PHARMACOKINETICS:
Tramadol is well absorbed after oral adminstration, reaching peak activity in 2 to 3 hours. Oral absorption of paracetamol following co-administration of tramadol and paracetamol, gives a peak plasma concentration of paracetamol within one hour and is not affected by co-administration with tramadol Tramadol and paracetamol are both extensively metabolised in tha liver. Approximately 30% of tramadol is excteted unchanged in the urine. Tramadol and its metabolites are eliminated primarily by the kidney. The plasme elimination half-lives of tramadol and its M1 metabolite are approximate 6 and 7 hours respectively. Paracetamol is eliminated from the body primarily by fomation of glucuronidr and sulfate conjugates in a dose-dependent manner. The half-life of paracetamol is about 2-3 hours in adults. Less than 9% of paracetamol is excreted  unchanged in the urine

INDICATIONS:
Tonoflex-P tablets are indicated for short term (Less than 5 days) management of acute pain

WARNINGS:
dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol containing products under medical supervision

serious Skin Reactions
Rarely, acetaminophen (paracetamol) may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidemal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity

Seizures
Seizures have been reported in patiens receiving tramadol at dosages within the recommended dosage range. The risk of seizures is enhanced in patients exceeding the recommended dose, or in patients taking tricyclic anti-depressants or other tricyclic e.g.promethazine, selective serotonin re-uptake inhibitors, MAO-inhibitors and neuroleptics

Drug Abuse and Dependence
Although tramadol has a low dependence potential, tolerance, psychic and physical dependence of the morphine-type may develop with long-tem use

Effects on Ability to Drive or Operate Machinery
Tramadol may affect reactions to the extent that driving ability and the ability and the ability to operate machinery may be impired. This applies particularly in cinjunction with other psychotropic medicines including alcohol

DOSAGE AND ADMINISTRATION:
To be used in adults and children over 16 years of age. Do not exceed the recommend dose

Acute Pain
2 tablets every 4 or 6 hours as needed for pain relief. Do not exceed 8 teblets per day

Renal Impairment
In patients with creatinine clearance less than 30ml/min, it is recommended that the dosing interval be increased not to exceed 2 tablets every 12 hours

PRECAUTIONS:

Pregnancy
Teratogenic Effect: pregnancy Category C
Safety during pregnancy and lactation has not been established. Tremadol has been show to cross the placenta

Children
Safety and efficacy have not been established

Elderly
Use with caution, reflecting the greater frequency of hepatic, renal, or cardiac function, and of concomitant disease and multiple drug therapy.
Tonoflex-P Tablets Tonoflex-P Tablets Reviewed by Athar on 00:57 Rating: 5

Normitab Tablets

00:26
Normitab Tablets
(Atenolol Tabler USP)

Normitab Tablets

COMPOSITION:
each film coated tablet contains:
Atenolol USP... 25mg, 50mg or 100mg.
USP specs.

INDICATION:
Management of hypertension, angina pectoris, cardiac dysrhythmias and myocardial infarction. Early intervention in the acute phase and long-term prophylaxis after recovery from myocardial infarction.

PHARMACOLOGICAL PROPERTIES:

pharmacodynamic properties: Atenolol is a β-blocker, which is β-selective, (i.e.acts preferentially on β-adrenergic receptors in the heart). Selectively decreases with increasing dose. Atenolol is without intrinsic sympathomimetic and membranestabilizing activities and as with other β-blockers, has negative inotropic effects (and is therefore contra-indicated in uncontrolled heart failure). As with other β-blockers, the mode of action of Atenolol in tha treatment of hypertension is unclear. It is probably the action of Atenolol in reducing cardiac rate and contractilit, which makes its effective in eliminating, or reducing the symptoms of parients with angina.

Pharmacokinetic Properties:
Absorption: Absorption of Atenolol following oral dosing is consistent but incomplete (approximately 40-50%) with peak plasma concentrations occurring 2-4 hours after dosing. The bioavailability is decreased by 20% when taken with food. There is a linear relationship between dosage and plasma concentration. The intersubject variability in AUC and Cmax is about 30-40%. There is no signiflcant hepatic metabolism of Atenolol an more than 90% of that absorbed reaches the systemic circulation unaltered.

Distribution: Atenolol penetrates tissues poorly due to its low lipid solubility and its concentration in brain tissue is low. The volume of distribution is 50 to 75 L. The protein binding is low (approximately 3%). Most of an absorbed dose (85-100%) is excreted unchanged via the urine.

Eliminating: This clearance is about 6L/h and the helf-little is about 6 to 9 hours. in elderly patients, clearance is decreased and elimination half-life increased. Thec clearnce is correlated renal function and the elimination is prolonged in patients with renal impairment. Impaired liver function dose not influence the phamacokinetics of Atenolol.

DOSAGE & ADMINISTRATION:

Adults: Hypertension: Most patients will respond to 100mg daily as single dose. The effect will be fully established in 1-2 weeks. A further reduction in blood pressure takes place by combining with other anti-hypertensive drugs. Simultaneously administered diuretic is highly effective and best suited anti hypertensive therapy.

Angina: Most patients with angina will respond to 100mg daliy in single or divided doses.
Normitab Tablets Normitab Tablets Reviewed by Athar on 00:26 Rating: 5

Paracetamol Tablet

03:16

Paracetamol Tablet

Paracetamol Tablet


makes use of

This drug is used to treat moderate to moderate pain (from headaches, menstrual intervals, toothaches, backaches, osteoarthritis, or bloodless/flu aches and pains) and to lessen fever.

how to use Paracetamol tablet
Take this product through mouth as directed. follow all instructions at the product packageif you are uncertain about any of the informationconsult your doctor or pharmacist.

there are numerous manufacturers and kinds of acetaminophen to be hadexamine the dosing instructionscautiously for every product due to the fact the amount of acetaminophen can be exceptional betweenmerchandise. Do now not take extra acetaminophen than encouraged. (See additionally warning segment.)

in case you are giving acetaminophen to a childmake sure you operate a product that is supposed for youngsters. Use your infant's weight to find the right dose on the product packageif you don't know your infant's weight, you can use their age.


facet outcomes

See also caution phase.

This drug usually has no aspect effectswhen you have any unusual resultscontact your doctor or pharmacist right away.

in case your medical doctor has directed you to use this medicinal drugkeep in mind that he or she has judged that the advantage to you is more than the threat of side outcomes. Many human beings using this remedy do now not have severe aspect effects.

a completely critical allergic reaction to this drug is rarehowever, get scientific assist proper away if younotice any signs of a severe allergytogether with: rash, itching/swelling (specifically of the face/tongue/throat), intense dizziness, trouble breathing.

This isn't always a entire list of possible side resultsin case you notice different outcomes now not indexedabove, touch your doctor or pharmacist.

Precautions

See additionally warning segment.

earlier than taking acetaminophen, tell your doctor or pharmacist in case you are allergic to it; or if you havesome other allergies. This product may also incorporate inactive ingredientswhich can reason allergic reactions or different problemsspeak in your pharmacist for extra information.

earlier than the usage of this product, inform your doctor or pharmacist your clinical recordsin particular of: liver diseasenormal use/abuse of alcohol.

Liquid products, chewable capsules, or dissolving/effervescent pills might also comprise sugar or aspartame. caution is recommended if you have diabetes, phenylketonuria (PKU), or any other circumstance that requiresyou to restrict/keep away from these substances to your weight loss planwhen you have any of theseconditions, ask your physician or pharmacist approximately using those products correctly.


  • tell your medical doctor if you are pregnant earlier than the use of this medicine.
Paracetamol Tablet Paracetamol Tablet Reviewed by Athar on 03:16 Rating: 5
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