Usage
This combination is primarily prescribed for female infertility, particularly in cases of irregular or absent ovulation, such as polycystic ovary syndrome (PCOS). It is also used to improve male fertility by enhancing sperm quality.
Clomiphene is a selective estrogen receptor modulator (SERM). Vitamin B6 is an essential vitamin. Coenzyme Q10 is an antioxidant. Zinc is an essential nutrient.
This combination works by stimulating the release of gonadotropin-releasing hormone (GnRH), which leads to increased secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). These hormones promote the development and maturation of ovarian follicles, ultimately leading to ovulation. Vitamin B6 helps regulate prolactin levels, which can interfere with ovulation if elevated. Zinc is crucial for egg production and hormone balance. Coenzyme Q10, as an antioxidant, protects developing eggs from free radical damage. In males, this combination improves sperm parameters.
Alternate Names
- Productiv-M Tablet
- Clofert Max Kit
How It Works
Pharmacodynamics: Clomiphene, a SERM, acts on the hypothalamus, pituitary gland, and ovaries. It primarily occupies estrogen receptors, reducing negative feedback and thereby increasing GnRH, FSH, and LH secretion. This hormonal cascade stimulates follicular growth and maturation, culminating in ovulation. Vitamin B6 contributes to normal hormonal balance, influencing prolactin levels and supporting reproductive function. Zinc is essential for cell division, growth, and hormone production, playing a role in ovarian function and egg development. Coenzyme Q10, a potent antioxidant, protects cells from oxidative stress, improving the quality of oocytes and sperm.
Pharmacokinetics: Clomiphene is well-absorbed orally. It is metabolized in the liver and primarily excreted in feces. Vitamin B6 is readily absorbed and converted to its active form, pyridoxal 5’-phosphate. It is mainly excreted in urine. Zinc absorption is influenced by dietary factors. It is stored in various tissues and eliminated primarily through feces. Coenzyme Q10 absorption can be variable. It is transported in lipoproteins and metabolized to ubiquinol.
Mode of Action: Clomiphene primarily acts by modulating estrogen receptor activity in the hypothalamus and pituitary gland, leading to increased gonadotropin release. Vitamin B6 acts as a cofactor for enzymes involved in various metabolic processes, including hormone synthesis. Zinc is essential for the function of numerous enzymes and transcription factors involved in reproductive processes. Coenzyme Q10 is a key component of the electron transport chain in mitochondria, acting as an antioxidant and protecting cells from oxidative damage.
Dosage
Standard Dosage
Children: This medication is not indicated for use in children.
Special Cases:
- Elderly Patients: No specific dosage adjustments are typically required, but caution is advised due to potential age-related decline in organ function.
- Patients with Renal Impairment: Dosage adjustment may not be necessary, but clinical monitoring is recommended.
- Patients with Hepatic Dysfunction: Use with caution, as this combination is considered potentially unsafe in patients with liver disease.
- Patients with Comorbid Conditions: Pre-existing conditions, including thyroid disorders, should be considered.
Clinical Use Cases
This drug combination isn’t typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is for infertility.
Dosage Adjustments
Dose modifications may be based on patient-specific factors like renal/hepatic dysfunction or response to therapy.
Side Effects
Common Side Effects
- Headache
- Nausea
- Hot flashes
- Breast discomfort
- Mood swings
- Visual disturbances (blurred vision, double vision)
- Abdominal distension
Rare but Serious Side Effects
- Ovarian hyperstimulation syndrome (OHSS) – symptoms include severe pelvic pain, bloating, nausea, vomiting, and rapid weight gain.
- Liver dysfunction
- Allergic reactions
Long-Term Effects
The long-term effects of this combination are not well-established, but prolonged use of clomiphene may be associated with an increased risk of ovarian cancer.
Contraindications
- Known hypersensitivity to any component of the combination
- Liver disease
- Ovarian cysts or enlargement not due to PCOS
- Abnormal uterine bleeding of undetermined origin
- Pregnancy
Drug Interactions
- Estrogens and oral contraceptives
- Anti-estrogens (e.g., tamoxifen)
- Antidepressants (e.g., SSRIs)
- Lipid-lowering agents (e.g., statins)
- Nitroglycerin
- Certain antibiotics (e.g., erythromycin)
Pregnancy and Breastfeeding
This combination is contraindicated during pregnancy and should be discontinued if pregnancy is confirmed. Clomiphene is classified as Pregnancy Category X. The safety of this combination during breastfeeding is not established, and it’s generally recommended to avoid it.
Drug Profile Summary
- Mechanism of Action: Stimulates ovulation through increased gonadotropin release; provides antioxidant protection and supports hormonal balance.
- Side Effects: Headache, nausea, hot flashes, breast discomfort, OHSS, visual disturbances.
- Contraindications: Hypersensitivity, liver disease, ovarian cysts, abnormal uterine bleeding, pregnancy.
- Drug Interactions: Estrogens, anti-estrogens, antidepressants, statins, nitroglycerin, certain antibiotics.
- Pregnancy & Breastfeeding: Contraindicated in pregnancy; avoid during breastfeeding.
- Dosage: One tablet daily for 5 days starting on day 5 of the menstrual cycle (adult females); male dosage varies.
- Monitoring Parameters: Ovarian response (ultrasound), hormone levels, liver function tests.
Popular Combinations
This combination itself is a popular formulation for female infertility.
Precautions
- Pre-screening for allergies, liver disease, and ovarian cysts.
- Monitor for OHSS and visual disturbances.
- Avoid alcohol and other drugs that may impair liver function.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clomiphene + Coenzyme Q10 + Vitamin B6 + Zinc?
A: For women, one tablet (containing 25mg clomiphene, 60mg CoQ10, 1.5mg vitamin B6, and 66mg zinc) daily for five days, starting on the 5th day of the menstrual cycle. For men, dosages vary based on formulation and clinical goals, consult a healthcare provider.
Q2: What are the primary uses of this combination?
A: Female infertility (especially in PCOS), male infertility (improving sperm quality).
Q3: What are the common side effects?
A: Headache, nausea, hot flashes, breast discomfort, mood changes, visual disturbances, and abdominal discomfort.
A: Ovarian hyperstimulation syndrome (OHSS), allergic reactions, and signs of liver dysfunction.
Q5: Can this combination be used during pregnancy or while breastfeeding?
A: No, it’s contraindicated in pregnancy (Pregnancy Category X) and generally advised to be avoided during breastfeeding.
Q6: What are the contraindications to using this combination?
A: Liver disease, abnormal uterine bleeding, ovarian cysts not due to PCOS, known allergy to any component.
Q7: What are the potential drug interactions with this medication?
A: Estrogens, anti-estrogens (e.g. tamoxifen), certain antidepressants, statins, and some antibiotics.
Q8: How does clomiphene work in this combination?
A: It acts as a SERM, stimulating the release of GnRH, FSH, and LH, ultimately inducing ovulation.
Q9: What is the role of CoQ10?
A: It acts as an antioxidant, protecting the developing eggs and sperm from free radical damage.
Q10: How does Vitamin B6 contribute to fertility?
A: It helps regulate hormone levels, especially prolactin, which can interfere with ovulation if elevated.
