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BIOMOL Suspension

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame. 


 


To promote this objective, not only we distribute and market our Analgesic range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Biomol Suspension which contains Paracetamol BP 120mg/5ml.

BIOMOL Suspension

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Details

COMPOSITION:

Each 5 ml contains:

Paracetamol BP           120 mg

 

CHEMICAL NAME:

N-(4-Hydroxyphenyl)acetamide. 

 

CATEGORY: Analgesic; antipyretic 

 

DESCRIPTION: Pink coloured homogenous suspension with pleasant flavour. 

 

CLINICAL PHARMACOLOGY

 

MECHANISM OF ACTION:

Acetaminophen is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.

 

INDICATIONS:

 

For the treatment of mild to moderate pain and as an antipyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds, flu and post-immunisation pyrexia.

 

CONTRAINDICATIONS

  • Hypersensitivity to any of the active ingredients.
  • The dosage in renal functional impairment must be reduced.
  • Should be taken with caution by asthmatics.
  • Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operation on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
  • Contra-indicated in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
  • Safety in pregnancy has not been established.

 

WARNING:

Dosage in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should only take paracetamol under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage.
Do not use continuously for more than 10 days without consulting your doctor. Store in a safe place out of the reach of children.

 

PRECAUTIONS:

Skin rashes and other allergic reactions may occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. In a few cases the use of paracetamol has been associated with the occurrence of thrombocytopaenia, neutropaenia, pancytopaenia, leucopaenia and agranulocytosis. The dose should be reduced in renal functional impairment.
Paracetamol should also be given with care to patients taking other drugs that affect the liver such as the barbiturates.

The absorption of paracetamol may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid.
Prolonged excessive use may cause irreversible kidney damage.

 

PREGNANCY AND LACTATION:

Use in Pregnancy (Category A)

Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Use in Lactation

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data does not contraindicate breast-feeding.

 

Effect to Drive & Use the Machine:

Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

Dosage in excess of those recommended may cause severe liver damage.

 

DOSAGE AND ADMINISTRATION:

 

Tablets:

1-2 tablets three to four times daily.

ADULTS: Take one to two tablets every four hours if necessary. Do not take more than 8 tablets per 24 hours.

CHILDREN: 6 - 12 years: Take half to one tablet every four hours, if necessary. Do not take more than 4 tablets per 24 hours.

It symptoms persist, consult your doctor. Do not use continuously for longer than 10 days without consulting your doctor.

Suspension:

6 - 12 years: Two to four 5ml spoonfuls.
1 - 6 years: One to two 5ml spoonfuls.
3 months - 1 year: Half to one 5ml spoonful.
Under 3 months: A 2.5ml spoonful is suitable for babies who develop fever following vaccination at 2 months. In all other cases use only under medical supervision.
Repeat dose every 4 - 6 hours as required up to a maximum of 4 doses in 24 hours.

DRUG INTERACTIONS:

Drugs which induce hepatic microsomal enzymes such as alcohol.

Concomitant barbiturates and tricyclic antidepressants may increase the hepatotoxicity of Paracetamol particularly after overdose. Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction. The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of Paracetamol with increased risk of bleeding; occasional doses have no significant effect.

OVERDOSAGE:  

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and non-specific myocardial depression have also occurred. In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. Prompt treatment is essential. Any patient who has ingested 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionin may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.

Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage. There is evidence that it is still effective up to 16 hours after overdosage with paracetamol and may be longer.

IV:        

An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.

Orally:

140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

 

Packing: Bottle of 60 ml.

 

Storage: Store below 30ºC. Protect from light. Do not freeze.

 

Shelf Life: 36 months from the date of manufacturing.

 

 
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