Description

Imipramine Tablets (10mg / 25mg / 50mg / 75mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Imipramine Hydrochloride Tablets in India. Imipramine is the prototype Tricyclic Antidepressant (TCA). While it has largely been replaced by SSRIs for mild depression, it remains a clinical gold standard for treating Melancholic Depression (severe depression) and is uniquely FDA-approved for the treatment of Nocturnal Enuresis (bedwetting) in children.

We offer Contract Manufacturing (Third Party) services for this classic neuropsychiatric drug. Imipramine has an intensely bitter and numbing taste. Our WHO-GMP certified facility in Mumbai utilizes traditional Sugar Coating (producing polished, elegant Red/Brown tablets) or advanced Flavor-Masked Film Coating to ensure patient compliance, which is critical in pediatric populations. Healthy Inc manages the export logistics, supplying psychiatric institutions and pediatric clinics across Africa, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Taste masking is the primary challenge.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Sugar Coating Expertise: Imipramine HCl is extremely bitter and causes a numbing sensation on the tongue. We possess dedicated sugar-coating pans to apply multiple layers of sucrose and color, creating a sealed barrier that completely hides the taste—essential for children taking it for bedwetting.

  • Dissolution Control: TCAs have a narrow therapeutic index (dose vs. toxicity). We strictly control the dissolution rate to prevent “dose dumping,” which could lead to dangerous heart rhythm spikes.

  • Content Uniformity: We ensure precise distribution of the API, especially in the low-dose 10mg and 25mg pediatric tablets.

• The Exporter: Healthy Inc

  • Child-Resistant Packaging: Since TCAs are highly toxic if taken in overdose, we strongly recommend and supply Child-Resistant Blisters (peel-push) or C-R bottle caps to prevent accidental ingestion by siblings.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for degradation products (iminodibenzyl) to ensure safety.

5. Why Use Imipramine?

It boosts mood and tightens the bladder.

• Mechanism (Depression): It blocks the reuptake of Norepinephrine and Serotonin in the brain, increasing their levels and improving mood.

• Mechanism (Bedwetting): It has mild Anticholinergic effects, which relaxes the bladder muscle (detrusor) while tightening the sphincter, increasing bladder capacity and preventing involuntary urination during sleep.

• Key Indications:

  • Depression: Especially severe forms where patients have lost appetite and sleep.

  • Nocturnal Enuresis: Bedwetting in children aged 6 years and older (short-term use).

  • Neuropathic Pain: (Off-label) Used for nerve pain, similar to Amitriptyline.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Imipramine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Tofranil?

  A: Tofranil is the brand name (Mallinckrodt). We manufacture the Generic Equivalent (Imipramine HCl).

• Q: Is it safe for children?

  A: Yes, but strictly monitored. It is approved for bedwetting in children >6 years. However, an overdose is extremely dangerous. Keep it locked away.

• Q: Does it cause dry mouth?

  A: Yes. Dry mouth, blurred vision, and constipation are common “anticholinergic” side effects. These usually lessen over time.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Depression (Adults): Start 25mg 3 times daily. Increase gradually to 150-200mg.

• Enuresis (Children 6+): Start 25mg one hour before bedtime. If no response, increase to 50mg (for <12 years) or 75mg (for >12 years).

• Duration (Enuresis): Max 3 months. Taper off slowly.

• Administration: Swallow whole. Do not chew (numbing taste).

9. Side Effects and Precautions

• Cardiotoxicity: Warning: Can cause arrhythmias and QT prolongation. Use with caution in patients with heart disease. Overdose can be fatal.

• Anticholinergic: Dry mouth, urinary retention, constipation, blurred vision.

• Orthostatic Hypotension: Dizziness upon standing up quickly.

• Suicidality: Monitor for worsening depression or suicidal thoughts during the first weeks of treatment.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.