Pivcilin
Generic Name
Pivmecillinam 200 mg tablet
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| pivcilin 200 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Pivmecillinam is a prodrug of mecillinam, a beta-lactam antibiotic belonging to the amidinopenicillin class. It is primarily used for the treatment of uncomplicated urinary tract infections (UTIs) caused by susceptible Gram-negative bacteria. Mecillinam exerts its antibacterial action by selectively binding to penicillin-binding protein 2 (PBP2) in the bacterial cell wall, leading to cell lysis and bacterial death.
Uses & Indications
Dosage
Adults
200 mg to 400 mg orally, two to three times daily. Typical dosage for uncomplicated UTI is 200 mg three times daily for 3-7 days.
Elderly
No specific dose adjustment is generally required, but caution is advised in patients with impaired renal function.
Renal_impairment
Creatinine clearance 10-30 mL/min: 200 mg two times daily. Creatinine clearance <10 mL/min: Not recommended or use with extreme caution and reduced dosage.
How to Take
Take orally with a glass of water. It is recommended to take the tablet with food to reduce gastrointestinal discomfort and enhance absorption. Tablets should be swallowed whole, not chewed or crushed.
Mechanism of Action
Pivmecillinam is hydrolyzed in the body to its active form, mecillinam. Mecillinam then selectively binds to penicillin-binding protein 2 (PBP2) located in the bacterial cell wall, which is crucial for maintaining the rod-like shape of Gram-negative bacteria. This binding inhibits transpeptidase activity, disrupting cell wall synthesis, leading to osmotic instability, cell lysis, and ultimately bacterial death.
Pharmacokinetics
Onset
Antibacterial effects begin shortly after absorption, clinical improvement typically within 24-48 hours.
Excretion
Primarily excreted unchanged by the kidneys via glomerular filtration and tubular secretion, resulting in high concentrations in the urine.
Half life
Approximately 1-2 hours for mecillinam.
Absorption
Well absorbed from the gastrointestinal tract after oral administration, hydrolyzed to mecillinam. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Pivmecillinam is a prodrug, rapidly hydrolyzed by esterases in the intestinal mucosa and blood to its active form, mecillinam. Minimal hepatic metabolism of mecillinam itself.
Side Effects
Contraindications
- Known hypersensitivity to pivmecillinam, other penicillins, or any component of the formulation.
- Severe carnitine deficiency (e.g., due to inherited metabolic disorders like glutaric aciduria type II).
- Acute porphyria.
Drug Interactions
Probenecid
Increases plasma concentrations and prolongs the half-life of mecillinam by reducing its renal tubular secretion.
Methotrexate
May increase methotrexate toxicity by impairing its renal elimination. Concomitant use should be monitored.
Sodium valproate
There is a theoretical concern that pivmecillinam may affect carnitine levels, which could interact with valproate's metabolism. Caution is advised.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include gastrointestinal disturbances like nausea, vomiting, diarrhea. In rare cases, central nervous system effects (e.g., convulsions) may occur, especially in patients with severe renal impairment. Treatment is symptomatic and supportive. Mecillinam can be removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Limited data in pregnant women indicate no increased risk of malformations. Use during pregnancy only if clearly needed. Mecillinam is excreted in breast milk in small amounts; generally considered compatible with breastfeeding, but monitor the infant for diarrhea or candidiasis.
Side Effects
Contraindications
- Known hypersensitivity to pivmecillinam, other penicillins, or any component of the formulation.
- Severe carnitine deficiency (e.g., due to inherited metabolic disorders like glutaric aciduria type II).
- Acute porphyria.
Drug Interactions
Probenecid
Increases plasma concentrations and prolongs the half-life of mecillinam by reducing its renal tubular secretion.
Methotrexate
May increase methotrexate toxicity by impairing its renal elimination. Concomitant use should be monitored.
Sodium valproate
There is a theoretical concern that pivmecillinam may affect carnitine levels, which could interact with valproate's metabolism. Caution is advised.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include gastrointestinal disturbances like nausea, vomiting, diarrhea. In rare cases, central nervous system effects (e.g., convulsions) may occur, especially in patients with severe renal impairment. Treatment is symptomatic and supportive. Mecillinam can be removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Limited data in pregnant women indicate no increased risk of malformations. Use during pregnancy only if clearly needed. Mecillinam is excreted in breast milk in small amounts; generally considered compatible with breastfeeding, but monitor the infant for diarrhea or candidiasis.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available, Patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of pivmecillinam for uncomplicated UTIs, demonstrating its specific activity against Gram-negative uropathogens and a favorable resistance profile compared to other common antibiotics. Studies have also explored its role in pregnant women and its impact on carnitine levels with prolonged use.
Lab Monitoring
- Renal function tests (for patients with impaired kidney function)
- Liver function tests (if signs of hepatic dysfunction occur)
- Complete blood count (for prolonged therapy)
Doctor Notes
- Pivmecillinam is highly concentrated in urine, making it an excellent choice for UTIs, especially those caused by ESBL-producing *E. coli* where other oral options may be limited.
- Counsel patients on the importance of completing the full course to prevent resistance.
- Be aware of potential carnitine depletion with prolonged use, especially in vulnerable populations.
Patient Guidelines
- Complete the full course of antibiotics as prescribed, even if symptoms improve.
- Take with food and plenty of water to minimize gastrointestinal upset.
- Inform your doctor if you develop a severe rash, difficulty breathing, or severe diarrhea.
- Avoid self-medication and strictly follow your doctor's instructions.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Pivmecillinam is generally not expected to affect the ability to drive or operate machinery. However, if side effects like dizziness or headache occur, avoid such activities until you feel well.
Lifestyle Advice
- Maintain good personal hygiene to prevent recurrent UTIs.
- Drink plenty of fluids to help flush out bacteria.
- Urinate frequently and empty your bladder completely.
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