Sosegon™
[Pentazocine]
Indications
Each ampoule containing Pentazocine (as Lactate) B.P, equivalent to 30 mg. Pentazocine base.
Contraindication
Hypersensitivity to pentazocine or any excipient.
Drug Interactions
Have no clinically significant drug interaction with other drugs.
Side Effects
The most commonly reported side effects are: nausea, vomiting, sedation, sweating, dizziness, and lightheadedness.Cardiovascular: hypertension, tachycardia, hypotension, and circulatory depression.Central and Peripheral Nervous System: hallucinations, visual blurring and focusing difficulty, headache, disorientation, disturbed dreams, insomnia, paresthesia, syncope, euphoria, grand mal convulsions, increase in intracranial pressure, confusion, tremor.Dermatologic/Allergic: dermatitis including pruritus, erythema multiform, toxic epidermal necrolysis have been reported.Gastrointestinal: constipation, dry mouth, biliary tract spasm, and abdominal pain.Hematologic: depression of white blood cell count, with rare cases of agranulocytosis usually reversible, moderate transient eosinophilia.Ophthalmic: miosis Respiratory: respiratory depression.Other: urinary retention, muscle tremor, chills, alterations in rate or strength of uterine contractions during labor Dependence & Withdrawal symptom (see Special Warnings and Precautions).
Warning and Precautions
WARNING: Pregnancy: In animal reproduction studies (rodents), teratogenic effects were reported only at doses high enough to cause maternal toxicity. The safe use of pentazocine in pregnant women (other than during labor) has not been established. Pentazocine should be used during pregnancy only if the physician judges the potential benefit to outweigh the risk.Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used narcotic analgesics.
Lactation: Pentazocine is excreted in human milk. Caution should therefore be observed in administering pentazocine to breast-feeding mothers.In chronic usage, care should be exercised to avoid any unnecessary increase in dosage since prolonged use of high doses of pentazocine may produce dependence.Keep this medication out reach of children.
PRECAUTIONS : Since pentazocine may produce sedation, dizziness, and occasionally euphoria, patients should be warned not to operate machinery or drive. Because respiratory depression is a side effect of agonist opioid therapy, particular caution should be observed when administering pentazocine to patients with respiratory conditions such as bronchial asthma, established respiratory depression, limited respiratory reserve, or obstructive respiratory conditions.
Dosage
The usual starting dose is 50 mg every 3-4 hours taken after meals. The dose may be adjusted according to the patient’s response. Total daily oral dose should not exceed 600mg.
Elderly: Elderly patients may require smaller and/or less frequent doses of pentazocine since renal or hepatic function impairment is often associated with aging.
Children: Clinical experience in children is limited.
Injection :Adults (Excluding Patients in Labor): Pentazocine lactate injections may be administered subcutaneously, intramuscularly, or intravenously. An initial single dose of 30 mg is recommended. Then the dosage may be adjusted according to patient response and pain severity. The injections may be repeated as necessary every three to four hours. A single dose should not normally exceed 1 mg/kg body weight subcutaneously or intramuscularly, or 0.5 mg/kg intravenously. The total daily dose should not exceed 360 mg.
Patients in Labor: Pentazocine may be administered as a single intramuscular dose of 30 mg. In some patients, an intravenous dose of 20 mg, repeated two or three times as needed at intervals of two to three hours has given adequate pain relief once contractions become regular (see Pregnancy and Lactation).
Elderly: Elderly patients may require smaller and/or less frequent doses of pentazocine since renal or hepatic function impairment is often associated with aging.
Children > 1 Year of Age: The maximum single dose of pentazocine lactate injection for pediatric patients is 1.0 mg/kg administered subcutaneously or intramuscularly, or 0.5 mg/kg intravenously. There are no dosage recommendations in children less than one year.
Presentations Available
Sosegon Tablets: Boxes of 100 (10 x 10’s blister packed tablets)
White tablets, each containing Pentazocine HCl USP, equivalent to 25 mg Pentazocine base
Sosegon Ampoule: 5 ampoules / box
Each ampoule containing Pentazocine (as Lactate) B.P, equivalent to 30 mg Pentazocine base
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