Description
Composition
Each Cineset tablet contains 90 mg of cinacalcet, equivalent to 99.18 mg of cinacalcet HCl. Additional ingredients include pre-gelatinized starch, microcrystalline cellulose PH 102, L-Hydroxypropyl cellulose-LH 11, crospovidone (Polyplasdone XL 10), colloidal silicon dioxide, and magnesium stearate. The tablet coating consists of Opadry II Green 32F210000 (hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG, indigo carmine, tartrazine (E102), sunset yellow (E110)), and Opadry Clear 03F190003 (hypromellose, macrogol/PEG).
Appearance
Cineset Film Tablet 90 Mg are green, oval, and imprinted with “90” on one side. They are available in blister packs, each containing 28 tablets.
Indications
Cineset is prescribed for several conditions related to the parathyroid glands:
- Secondary Hyperparathyroidism: Used in patients with severe kidney disease requiring dialysis to control elevated PTH levels.
- Parathyroid Cancer: Helps reduce high calcium levels in patients with parathyroid cancer.
- Primary Hyperparathyroidism: Manages high calcium levels in patients when surgical removal of the gland is not an option.
Drug Interactions
Cineset Film Tablet 90 Mg, containing cinacalcet, can interact with other medications, potentially altering their effects or causing adverse reactions. Consulting with a healthcare professional before starting any new medication is crucial.
Types of Drug Interactions
- Drug-Drug Interaction: When a medication reacts with one or more other drugs, such as combining a cough medicine with a sleep aid, causing potential side effects.
- Drug-Food/Drink Interaction: When food or drink affects a drug, like alcohol interacting with certain medications.
- Drug-Condition Interaction: When a health condition makes taking certain medications risky, such as high blood pressure patients taking a decongestant.
Specific Interactions with Cinacalcet
While specific interactions are not extensively documented, general guidelines include avoiding drugs with the same active ingredient, being cautious with blood thinners and NSAIDs, and avoiding combinations that could slow reaction times, such as antihistamines.
Onset of Action
Cineset Film Tablet 90 Mg works by increasing the sensitivity of the calcium-sensing receptor on the parathyroid gland, lowering PTH, calcium, and phosphorus levels.
- Time to Peak: Peak levels are reached approximately 2 to 6 hours after oral administration.
- Half-Life: The half-life is between 30 to 40 hours.
Effects might be noticeable within a few hours to days, but achieving targeted PTH levels may require dose adjustments over 2 to 4 weeks.
Side Effects
Cineset can cause various side effects, which are important to recognize for timely medical intervention.
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
Serious Side Effects
- Numbness or tingling around the mouth
- Muscle pain or tightness
- Seizures
- Shortness of breath
- Rapid weight gain
- Signs of stomach bleeding
Recommended Dosage
Dosage varies based on the condition being treated and individual response.
Secondary Hyperparathyroidism
- Initial Dose: 30 mg orally once a day.
- Titration: Every 2 to 4 weeks through doses of 30, 60, 90, 120, and 180 mg to target iPTH levels of 150 to 300 pg/mL.
- Maximum Dose: 180 mg orally once a day.
Hypercalcemia of Malignancy
- Initial Dose: 30 mg orally twice a day.
- Titration: Every 2 to 4 weeks through doses of 30 mg orally twice a day, up to 90 mg 3 or 4 times a day.
- Maintenance Dose: 60 to 360 mg orally per day.
- Maximum Dose: 90 mg orally 4 times a day.
Primary Hyperparathyroidism
- Initial Dose: 30 mg orally twice a day.
- Titration: Every 2 to 4 weeks through doses of 30 mg orally twice a day, up to 90 mg 3 or 4 times a day.
- Maintenance Dose: 60 to 360 mg orally per day.
Benefits of Cineset Film Tablet 90 Mg
Cineset offers significant benefits in managing parathyroid gland-related conditions.
Management of Secondary Hyperparathyroidism
- Reduces PTH production in patients with kidney disease on dialysis, balancing calcium and phosphorus levels.
Treatment of Primary Hyperparathyroidism
- Manages symptoms when surgical removal is not an option by reducing PTH levels.
Management of Parathyroid Cancer
- Lowers high blood calcium levels, preventing complications such as kidney stones, bone loss, and heart disease.
Precautions for Cineset Film Tablet 90 Mg
Precautions are essential to ensure safe and effective use of Cineset.
Contraindications
- Allergy: Do not use if allergic to cinacalcet or other ingredients.
- Low Calcium Levels: Avoid starting treatment if serum calcium is below the normal range.
Warnings and Precautions
- Hypocalcemia: Monitor for signs of low serum calcium, such as numbness and muscle tightness.
- Drug Interactions: Cinacalcet is metabolized by CYP3A4, requiring dose adjustments if combined with strong CYP3A4 inhibitors.
Use in Specific Populations
- Pregnancy: Limited case reports; consult a healthcare provider for risk assessment.
Overdosage
Overdosage can lead to hypocalcemia. Monitoring and corrective measures are necessary in such cases.
Conclusion
Cineset Film Tablet 90 Mg is a vital medication for managing conditions related to the parathyroid glands. Proper administration and monitoring are essential to maximize benefits and minimize risks. Always consult with a healthcare professional for personalized medical advice.
Aspect | Details |
---|---|
Indications | Secondary hyperparathyroidism, parathyroid cancer, primary hyperparathyroidism |
Common Side Effects | Nausea, vomiting, diarrhea |
Serious Side Effects | Numbness, muscle pain, seizures, shortness of breath, stomach bleeding |
Dosage | Varies by condition; generally 30 mg once or twice daily with titration to a maximum of 180 mg |
Benefits | Reduces PTH production, manages hypercalcemia, treats secondary and primary hyperparathyroidism |
Precautions | Monitor for hypocalcemia, adjust dose for CYP3A4 inhibitors, contraindicated in low calcium levels |
Onset of Action | Peak levels in 2-6 hours, half-life of 30-40 hours |
Drug Interactions | Avoid combinations with similar drugs, caution with blood thinners, antihistamines |
Overdosage | Monitor and correct serum calcium levels |
This comprehensive overview provides essential information on the use, benefits, and precautions associated with Cineset Film Tablet 90 Mg, ensuring informed and safe use of the medication.
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