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FRANEEL Imipramine Hydrochloride Tablets and

Imipramine Tablets

FRANEEL 10: Each sugar-coated tablet contains Imipramine Hydrochloride BP 10 mg.

FRANEEL 25: Each sugar-coated tablet contains Imipramine Hydrochloride BP 25 mg; excipients q.s.

Usage: Prescription treatment of depression; other uses require specialist evaluation.

Category: Antidepressant Drugs

Therapeutic Category: Tricyclic Antidepressant (TCA)

SKU: Imipramine Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Imipramine Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Imipramine Hydrochloride Tablets BP 10 mg / 25 mg

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. presents Imipramine Hydrochloride Tablets, a tricyclic antidepressant (TCA) used for depression and, in selected settings, nocturnal enuresis. The supplied products are FRANEEL 10 and FRANEEL 25, both sugar-coated tablets containing imipramine hydrochloride BP. Clinical use, especially in children, requires careful supervision.

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

2. Product Specifications

ProductComposition per tabletDosage form
FRANEEL 10 / Imipramine Tablets BP 10 mgImipramine Hydrochloride BP 10 mgSugar-coated tablet
FRANEEL 25 / Imipramine Tablets BP 25 mgImipramine Hydrochloride BP 25 mg; excipients q.s.Sugar-coated tablet

Generic name: Imipramine Hydrochloride. Therapeutic class: Tricyclic antidepressant. 50 mg and 75 mg strengths: mentioned in the supplied background description but not supported by the supplied product compositions. Confirm packaging, shelf life and release specifications against approved documentation.

3. Manufacturing Technology

Formulating sugar-coated imipramine tablets involves uniform distribution of low-dose active ingredient, reproducible compression, coating quality and appropriate protection during packaging. Sugar coating can help mask an unpleasant taste. Particular processes, equipment, manufacturing-site conditions and child-resistant pack configurations should be confirmed from the product-specific manufacturing records rather than assumed.

4. Quality Assurance

Quality controls should include identity, assay, uniformity of dosage units, dissolution, related substances and stability testing in accordance with the approved BP specification and local registration requirements. Exact acceptance limits, shelf life and bioequivalence are product-specific and require supporting documentation.

5. Pharmacology and Clinical Use

Imipramine inhibits neuronal reuptake of norepinephrine and serotonin. It is prescribed for certain depressive disorders and may be used for nocturnal enuresis in appropriately selected children under specialist supervision, depending on local authorization. It is not a first-choice treatment for every patient; cardiac safety, overdose risk and alternatives must be assessed. Other off-label uses require individual clinical judgment.

6. Export and Regulatory Support

For contract manufacturing and export enquiries, request the applicable certificate of analysis, approved specifications, stability data, manufacturing authorizations and registration documents. CTD/ACTD dossiers, certificates and market eligibility depend on the product and destination jurisdiction; availability should be confirmed with the supplier.

7. Frequently Asked Questions

Q: Which FRANEEL variants are listed?
A: FRANEEL 10 (10 mg) and FRANEEL 25 (25 mg), both sugar-coated imipramine hydrochloride BP tablets.

Q: Is imipramine related to Tofranil?
A: Imipramine is the active ingredient in certain Tofranil products. Equivalence of a specific product requires appropriate regulatory evidence.

Q: Is imipramine safe for children?
A: It carries substantial overdose and cardiac risks; any use for bedwetting must be prescribed and monitored by a qualified clinician.

Q: Does it cause dry mouth?
A: Yes. Dry mouth, constipation, blurred vision and urinary retention are possible anticholinergic effects.

8. Dosage and Administration

Take only as prescribed and follow the approved product label. Dosing differs by age, indication, other illnesses and concurrent medicines. For nocturnal enuresis, a clinician must assess suitability, dosing, treatment duration and monitoring; do not use unsupervised pediatric schedules. Do not abruptly discontinue without medical advice. Swallow the sugar-coated tablets as directed.

9. Side Effects and Precautions

  • Cardiac and overdose risks: Imipramine can cause conduction abnormalities, arrhythmias and serious toxicity in overdose. Seek emergency care immediately after suspected overdose.
  • Suicidality: Antidepressants can increase suicidal thoughts or behaviors in some children, adolescents and young adults; close monitoring is important.
  • Anticholinergic effects: Dry mouth, constipation, blurred vision and difficulty urinating.
  • Other effects: Sedation, dizziness, orthostatic hypotension and possible weight changes.
  • Interactions and contraindications: Inform the prescriber about MAO inhibitors, other serotonergic or QT-prolonging drugs, glaucoma, urinary retention, seizure disorders and heart disease.
  • Child safety: Store securely; even small accidental ingestions can be dangerous.

10. Storage Instructions

Store in the original packaging in a dry place protected from excessive heat and moisture, following the approved pack label. Keep securely out of reach of children.