Usage
This combination medication is primarily prescribed for female infertility, particularly in women experiencing anovulation (failure to release eggs) or ovulatory dysfunction. It is used in cases of infertility related to polycystic ovary syndrome (PCOS) and unexplained infertility where ovulation is irregular or absent.
Pharmacological Classifications:
- Clomiphene: Selective Estrogen Receptor Modulator (SERM)
- Acetylcysteine: Mucolytic
- Coenzyme Q10: Antioxidant
Mechanism of Action:
- Clomiphene: Stimulates the release of gonadotropins (FSH and LH) by binding to estrogen receptors in the brain, mimicking a low estrogen state. This hormonal cascade promotes follicle development in the ovaries, leading to ovulation.
- Acetylcysteine: Thins the cervical mucus, counteracting the thickening effect of clomiphene, which can hinder sperm penetration.
- Coenzyme Q10 (Ubiquinone): A potent antioxidant, protecting cells from free radical damage and supporting mitochondrial function, potentially improving egg quality and overall ovarian health.
Alternate Names
This specific combination doesn’t have a universally recognized international nonproprietary name (INN). It is often referred to by the names of its individual components. Some brand names include:
- Clomeva NC 50mg Tablet
- Smartova 50 Combipack
- Smartova 100 Combipack
- E Ova Plus 50mg Tablet
- E Ova Plus 5075600 Mg Tablet
How It Works
Pharmacodynamics:
- Clomiphene: Induces ovulation by increasing gonadotropin secretion, thereby stimulating ovarian follicular development and maturation.
- Acetylcysteine: Reduces mucus viscosity by disrupting disulfide bonds in mucoproteins.
- Coenzyme Q10: Enhances mitochondrial energy production and acts as a free radical scavenger.
Pharmacokinetics:
Specific pharmacokinetic data for the combination are limited. Information is generally available for individual components. Clomiphene is readily absorbed orally and extensively metabolized in the liver. Acetylcysteine is also well-absorbed orally and metabolized in the liver. Coenzyme Q10 absorption can vary and is improved with food.
Mode of Action:
- Clomiphene: Binds to estrogen receptors in the hypothalamus and pituitary, modulating feedback mechanisms and increasing gonadotropin release.
- Acetylcysteine: Exerts its mucolytic action through breaking down disulfide bonds in mucus glycoproteins.
- Coenzyme Q10: Participates in the electron transport chain in mitochondria, supporting ATP synthesis, and scavenges free radicals, protecting against oxidative stress.
Elimination Pathways:
- Clomiphene: Primarily excreted in feces, with some renal excretion.
- Acetylcysteine: Metabolized in the liver and excreted primarily in the urine.
- Coenzyme Q10: Primarily eliminated through biliary excretion.
Dosage
Dosage guidelines for the fixed-dose combination are limited. Dosages are determined by physicians based on individual patient needs and response.
Standard Dosage
Adults:
Standard dosage guidelines for this specific combination aren’t consistently defined in available literature. Dosages will be determined by the physician based on individual patient needs. Clomiphene is often started at 50 mg daily for 5 days, usually beginning on day 5 of the menstrual cycle. Coenzyme Q10 is often given as a supplement at doses ranging from 100mg to 300mg per day. Acetylcysteine dosages vary considerably depending on the specific indication.
Children:
This combination is not indicated for use in children.
Special Cases:
- Elderly Patients: Clinical judgment should guide dosage. Limited data exists regarding age-related adjustments.
- Patients with Renal Impairment: Caution is warranted. Dosage adjustments may be necessary.
- Patients with Hepatic Dysfunction: Contraindicated in patients with liver disease.
- Patients with Comorbid Conditions: Use with caution in patients with thyroid disorders, uncontrolled adrenal dysfunction, ovarian cysts (not due to PCOS), abnormal uterine bleeding. Dosage adjustments may be needed.
Clinical Use Cases
This combination is not typically used in settings like intubation, surgical procedures, mechanical ventilation, or emergency situations. Its primary role is in treating ovulatory dysfunction in female infertility.
Dosage Adjustments
Dosage adjustments are made based on individual patient response and clinical assessment, including monitoring of follicular development and endometrial thickness via ultrasound.
Side Effects
Common Side Effects
- Nausea and vomiting
- Headache
- Hot flashes
- Breast discomfort
- Mood swings
- Bloating
- Abdominal discomfort
- Blurred vision
Rare but Serious Side Effects
- Ovarian Hyperstimulation Syndrome (OHSS): Manifests as severe pelvic pain, abdominal distension, nausea, vomiting, rapid weight gain. Requires urgent medical attention.
- Visual disturbances (spots or flashes, double vision)
Long-Term Effects
Data on long-term effects is limited.
Adverse Drug Reactions (ADR)
OHSS is a significant ADR requiring prompt intervention.
Contraindications
- Hypersensitivity to any component of the medication
- Liver disease
- Ovarian cysts or enlargement not due to PCOS
- Undiagnosed abnormal uterine bleeding
- Uncontrolled thyroid or adrenal dysfunction
Drug Interactions
- Estrogens, oral contraceptives (e.g., ethinyl estradiol)
- Anti-estrogens (e.g., tamoxifen)
- Antidepressants (e.g., SSRIs like sertraline)
- Lipid-lowering agents (e.g., statins)
- Nitroglycerin
- Some antibiotics (e.g., erythromycin)
- Anticoagulants (e.g., warfarin)
- Antidiabetic medications (e.g., metformin, glipizide)
- Chemotherapy drugs (e.g., doxorubicin)
- Antihypertensives (e.g., losartan, valsartan)
Pregnancy and Breastfeeding
This combination is contraindicated in pregnancy and breastfeeding. Clomiphene can have teratogenic effects.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Determined by physician based on individual patient factors.
- Monitoring Parameters: Follicular development and endometrial thickness (via ultrasound), pregnancy tests.
Popular Combinations
This combination itself represents a clinically used combination of three agents.
Precautions
- Evaluate for contraindications and potential drug interactions before starting therapy.
- Monitor for side effects, especially OHSS.
- Counsel patients about the potential for multiple pregnancies.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Acetylcysteine + Clomiphene + Coenzyme Q10?
A: The precise dosage is individualized and determined by the physician based on patient-specific factors. Clomiphene typically begins at 50mg daily for 5 days, commencing on the 5th day of the menstrual cycle. CoQ10 is frequently supplemented at doses between 100mg and 300mg daily. Acetylcysteine dosage depends on its specific indication.
Q2: How does this combination improve fertility?
A: The combination works synergistically: clomiphene stimulates ovulation, acetylcysteine improves cervical mucus consistency for sperm penetration, and CoQ10 enhances egg quality and ovarian health.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, headache, hot flashes, breast discomfort, bloating, and mood changes.
Q4: Are there any serious side effects?
A: Yes, a rare but serious side effect is Ovarian Hyperstimulation Syndrome (OHSS).
Q5: Who should not take this medication?
A: Patients with liver disease, uncontrolled thyroid or adrenal dysfunction, ovarian cysts (not caused by PCOS), and unexplained abnormal uterine bleeding should not take this combination. Also contraindicated in those with hypersensitivity to any component.
Q6: Can this medication be used during pregnancy?
A: No, this combination is contraindicated during pregnancy and breastfeeding.
Q7: What medications interact with this combination?
A: Several medications can interact, including estrogens, anti-estrogens, some antidepressants, statins, nitroglycerin, certain antibiotics, and some blood thinners. A full medication review is necessary.
Q8: How should patients be monitored during treatment?
A: Patients should be closely monitored for side effects, and follicular development and endometrial thickness should be assessed via ultrasound.
Q9: What is the role of CoQ10 in this combination?
A: CoQ10 acts as an antioxidant, potentially improving egg quality and protecting the ovaries from oxidative stress. It also plays a vital role in mitochondrial function, contributing to cellular energy production.
Q10: How long can a patient take this combination?
A: The duration of treatment is determined by the physician and typically limited to a few cycles due to the potential for clomiphene-related side effects and the need to reassess treatment strategy if pregnancy is not achieved.
