Hemax-PG
Generic Name
Pregabalin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| hemax pg 500 mg capsule | ৳ 2.00 | ৳ 20.00 |
Description
Overview of the medicine
Hemax-PG 500 mg Capsule contains Pregabalin, an anticonvulsant and neuropathic pain agent. It is used to treat neuropathic pain, fibromyalgia, and as an adjunctive therapy for partial onset seizures in adults. The 500 mg strength is typically used for severe conditions or as an extended-release formulation, requiring careful medical supervision.
Uses & Indications
Dosage
Adults
Dosage typically ranges from 150 mg to 600 mg per day, divided into 2 or 3 doses. Due to the high strength of 500 mg, this capsule is generally prescribed for specific conditions requiring higher initial doses or as a once-daily extended-release equivalent. Strict adherence to physician's instructions is crucial.
Elderly
Dosage adjustment may be necessary due to age-related decrease in renal function. Start with lower doses and titrate gradually.
Renal_impairment
Dosage must be reduced significantly based on creatinine clearance. For example, for CrCl <30 mL/min, maximum recommended dose is 75-150 mg/day, divided. The 500 mg strength is generally unsuitable for patients with severe renal impairment.
How to Take
Take orally with or without food. Swallow the capsule whole with water. Do not crush, chew, or open the capsule.
Mechanism of Action
Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, leading to a reduction in the release of excitatory neurotransmitters. This action is thought to underlie its analgesic, anxiolytic, and anticonvulsant effects.
Pharmacokinetics
Onset
Pain relief may begin within one week of treatment for neuropathic pain. Antiepileptic effects also observed early in therapy.
Excretion
Primarily excreted unchanged in the urine, with renal clearance directly proportional to creatinine clearance.
Half life
Approximately 6.3 hours, consistent across doses and multiple administrations.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically occur within 1.5 hours. Bioavailability is ≥90% and is not affected by food.
Metabolism
Negligible hepatic metabolism in humans; approximately 98% of the dose is excreted unchanged in urine.
Side Effects
Contraindications
- Known hypersensitivity to Pregabalin or any components of the formulation.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Drug Interactions
Ethanol (Alcohol)
Increased CNS depressant effects. Avoid alcohol consumption during treatment.
Opioids (e.g., Oxycodone, Morphine)
May potentiate the effects of opioids and other CNS depressants, leading to increased sedation and respiratory depression. Use with caution, especially in elderly patients or those with respiratory compromise.
Benzodiazepines (e.g., Lorazepam, Diazepam)
Increased risk of sedation, dizziness, and CNS depression. Concomitant use should be avoided or used with extreme caution.
Thiazolidinedione antidiabetic agents (e.g., Rosiglitazone, Pioglitazone)
May increase risk of weight gain and peripheral edema when used concurrently.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include somnolence, confusion, agitation, and restlessness. Acute kidney failure has been reported. Treatment should involve general supportive measures and may include gastric lavage if ingestion is recent. Hemodialysis can effectively remove Pregabalin from plasma.
Pregnancy & Lactation
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hemax-PG should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Known hypersensitivity to Pregabalin or any components of the formulation.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Drug Interactions
Ethanol (Alcohol)
Increased CNS depressant effects. Avoid alcohol consumption during treatment.
Opioids (e.g., Oxycodone, Morphine)
May potentiate the effects of opioids and other CNS depressants, leading to increased sedation and respiratory depression. Use with caution, especially in elderly patients or those with respiratory compromise.
Benzodiazepines (e.g., Lorazepam, Diazepam)
Increased risk of sedation, dizziness, and CNS depression. Concomitant use should be avoided or used with extreme caution.
Thiazolidinedione antidiabetic agents (e.g., Rosiglitazone, Pioglitazone)
May increase risk of weight gain and peripheral edema when used concurrently.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include somnolence, confusion, agitation, and restlessness. Acute kidney failure has been reported. Treatment should involve general supportive measures and may include gastric lavage if ingestion is recent. Hemodialysis can effectively remove Pregabalin from plasma.
Pregnancy & Lactation
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Hemax-PG should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the manufacturing date, consult package for exact expiry.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Patent expired for generic formulations
Clinical Trials
Pregabalin has undergone extensive clinical trials demonstrating its efficacy and safety in various indications, including neuropathic pain, fibromyalgia, and epilepsy. Studies have shown significant reductions in pain scores and seizure frequency compared to placebo.
Lab Monitoring
- Monitor renal function (creatinine clearance) periodically, especially in elderly patients and those with known renal impairment, and adjust dosage accordingly.
- Observe for signs and symptoms of angioedema or severe dermatological reactions.
- Monitor for worsening depression, suicidal thoughts, or unusual changes in mood or behavior.
Doctor Notes
- Counsel patients on the importance of adherence and gradual dose titration to minimize withdrawal symptoms and adverse effects.
- Assess patients for a history of substance abuse prior to initiating therapy, and monitor for signs of abuse and dependence during treatment.
- Educate patients about the potential for CNS depressant effects and interactions with alcohol and other CNS depressants. Advise against driving or operating machinery until effects are known.
Patient Guidelines
- Do not stop taking Hemax-PG suddenly without consulting your doctor, as it may lead to withdrawal symptoms such as insomnia, headache, nausea, anxiety, diarrhea, or seizures.
- Avoid driving or operating heavy machinery until you are aware of how this medicine affects your ability to perform such tasks, as it can cause dizziness and somnolence.
- Report any unusual mood changes, suicidal thoughts, allergic reactions (swelling of face, lips, tongue), or muscle pain/weakness to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Hemax-PG may cause dizziness, somnolence, blurred vision, and impaired concentration. Patients should be advised not to drive, operate complex machinery, or engage in other potentially hazardous activities until they are certain that Pregabalin does not adversely affect their ability to do so.
Lifestyle Advice
- Maintain a healthy diet and engage in regular exercise to manage potential weight gain associated with Pregabalin.
- Limit or avoid alcohol consumption during treatment, as it can exacerbate CNS depressant effects.
- If you have diabetes, continue to monitor your blood sugar levels regularly as advised by your doctor.
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