Medicine Information

Nipotin

Name: Nipotin
Brand: Nipotin

Injection (Powder for solution)5000 IUGonadotropins, Pituitary & Hypothalamic Hormones & AnaloguesATC: G03GA01

Generic Name

Human Chorionic Gonadotropin (hCG)

Manufacturer

Example Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
nipotin 5000 iu injection	৳ 2,150.00	N/A

Description

Overview of the medicine

Nipotin 5000 IU Injection contains Human Chorionic Gonadotropin (hCG), a hormone identical to the natural hormone produced by the placenta during pregnancy. It is used in fertility treatments to stimulate ovulation in women and sperm production in men, as well as for certain other endocrine conditions.

Uses & Indications

Induction of ovulation and pregnancy in anovulatory infertile women, after stimulation of follicular development.

Support of the luteal phase in Assisted Reproductive Technology (ART) programs.

Treatment of hypogonadotropic hypogonadism in males (e.g., delayed puberty, cryptorchidism not due to anatomical obstruction).

Diagnosis of cryptorchidism.

Dosage

Adults

Female: Typically 5,000 to 10,000 IU administered one day after the last dose of FSH or hMG. Male (Hypogonadotropic Hypogonadism): 500-4,000 IU 2-3 times per week, depending on condition and response. Male (Cryptorchidism): 500-1,000 IU 3 times weekly for 4-6 weeks.

Elderly

Use with caution. Dosage adjustments may be needed based on individual response and renal/hepatic function.

Renal_impairment

No specific dosage adjustment guidelines for renal impairment are available. Use with caution.

How to Take

Administered intramuscularly (IM) or subcutaneously (SC) after reconstitution with the provided solvent. The injection should be prepared and administered by a healthcare professional, or by the patient after proper training.

Mechanism of Action

hCG acts similarly to Luteinizing Hormone (LH). In women, it triggers ovulation in ripe ovarian follicles following FSH or hMG therapy. In men, it stimulates Leydig cells in the testes to produce androgens, leading to spermatogenesis. It is also used to induce descent of undescended testes.

Pharmacokinetics

Onset

Ovulation typically occurs 36-40 hours after a single dose in women. Effects on spermatogenesis develop over weeks to months.

Excretion

Excreted predominantly in the urine, mainly as metabolites, with a small percentage as unchanged drug.

Half life

Approximately 29-30 hours (terminal half-life).

Absorption

Rapidly absorbed after intramuscular (IM) or subcutaneous (SC) injection. Peak plasma concentrations are reached within approximately 6 hours for IM and 10-16 hours for SC.

Metabolism

Primarily metabolized in the liver and kidneys.

Side Effects

Contraindications

Hypersensitivity to hCG or any component of the formulation.
Sex hormone dependent tumors (e.g., breast, uterine, ovarian, prostatic carcinoma).
Primary ovarian failure or testicular failure.
Uncontrolled thyroid or adrenal dysfunction.
Abnormal vaginal bleeding of undetermined origin.
Ovarian cysts or enlargement not due to Polycystic Ovarian Syndrome (PCOS).
Uterine fibroids or other conditions that contraindicate pregnancy.

Drug Interactions

Other fertility medications

No significant adverse drug interactions have been reported with concomitant use of hCG with other fertility medications like FSH or hMG; however, overall treatment plan should be carefully monitored.

Storage

Store unopened vials at 2°C to 25°C (36°F to 77°F), protected from light. Do not freeze. Reconstituted solution should not be stored and must be used immediately.

Overdose

Overdose may lead to Ovarian Hyperstimulation Syndrome (OHSS) in women, which requires immediate medical attention. Management is primarily symptomatic and supportive.

Pregnancy & Lactation

Pregnancy: hCG is used to induce pregnancy but is not indicated for use during an established pregnancy. Lactation: Not recommended for use during lactation, as hCG may pass into breast milk and its effects on the infant are unknown.

Side Effects

Contraindications

Hypersensitivity to hCG or any component of the formulation.
Sex hormone dependent tumors (e.g., breast, uterine, ovarian, prostatic carcinoma).
Primary ovarian failure or testicular failure.
Uncontrolled thyroid or adrenal dysfunction.
Abnormal vaginal bleeding of undetermined origin.
Ovarian cysts or enlargement not due to Polycystic Ovarian Syndrome (PCOS).
Uterine fibroids or other conditions that contraindicate pregnancy.

Drug Interactions

Other fertility medications

Storage

Store unopened vials at 2°C to 25°C (36°F to 77°F), protected from light. Do not freeze. Reconstituted solution should not be stored and must be used immediately.

Overdose

Overdose may lead to Ovarian Hyperstimulation Syndrome (OHSS) in women, which requires immediate medical attention. Management is primarily symptomatic and supportive.

Pregnancy & Lactation

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1 vial of 5000 IU + 1 ampoule of solvent

Shelf Life

Typically 2-3 years for unopened vials when stored correctly. Reconstituted solution should be used immediately and discarded if not used within a few hours (refer to specific product leaflet).

Availability

Pharmacies, Hospitals, Fertility Clinics

Approval Status

Approved by major regulatory authorities worldwide (e.g., FDA, EMA)

Patent Status

Generic available, original patent expired

WHO Essential Medicine

Yes

Clinical Trials

hCG has been extensively studied in clinical trials for its efficacy in ovulation induction, male hypogonadism, and cryptorchidism. Ongoing research focuses on optimizing dosages, administration protocols, and exploring new applications.

Lab Monitoring

Serum estradiol levels (during ovarian stimulation to assess follicular development and OHSS risk)
Ultrasonography to monitor follicular development and endometrial thickness
Serum testosterone levels (in males receiving treatment for hypogonadism)

Doctor Notes

Thorough patient counseling on the risks of Ovarian Hyperstimulation Syndrome (OHSS) and multiple pregnancies is essential prior to initiating hCG therapy.
Strict monitoring of follicular development via ultrasound and serum estradiol levels is crucial to minimize risks and optimize treatment outcomes.
Ensure proper reconstitution technique is demonstrated to patients if self-administration is intended, or administered by a qualified healthcare professional.
Patients should be advised to report any signs of thromboembolic events promptly.

Patient Guidelines

Follow your doctor's instructions meticulously regarding dosage, administration, and monitoring schedule.
Report any unusual side effects or signs of Ovarian Hyperstimulation Syndrome (OHSS) immediately (e.g., severe abdominal pain, bloating, sudden weight gain, decreased urine output).
Attend all scheduled appointments for blood tests and ultrasounds.
Understand the risks of multiple pregnancies and OHSS before starting treatment.

Missed Dose Advice

If a dose is missed, contact your doctor or fertility specialist immediately for advice. Do not take a double dose to make up for a missed one.

Driving Precautions

Nipotin 5000 IU Injection is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or other side effects that impair concentration, avoid these activities until you feel well.