Triptorelin
Generic Name: triptorelin
Brand Names:
Triptodur
11 DESCRIPTION TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt).
Overview
11 DESCRIPTION TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt).
Uses
1 INDICATIONS AND USAGE TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Must only be administered by a healthcare provider. ( 2.1 ) Administer TRIPTODUR as a single intramuscular injection of 22.5 mg once every 24 weeks. ( 2.1 ) Monitor response with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose. ( 2.2 ) Measure height every 3-6 months and monitor bone age periodically. ( 2.2 ) See FPI for complete reconstitution and administration instructions. ( 2.3 ) Once TRIPTODUR is mixed, proceed to the next steps and administer without delay.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial Rise of Gonadotropins and Sex Steroid Levels [ see Warnings and Precautions ( 5.1 ) ] Psychiatric Events [ see Warnings and Precautions ( 5.2 ) ] Convulsions [ see Warnings and Precautions ( 5.3 ) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.4 ) ] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 ) ] In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infec...
Interactions
7 DRUG INTERACTIONS 7.1 Drug-Drug Interactions Results of in vitro studies show that drug-drug interactions with triptorelin are unlikely [see Clinical Pharmacology (12.3)] . However, in the absence of relevant data and as a precaution, hyperprolactinemic drugs should not be used concomitantly with triptorelin since hyperprolactinemia reduces the number of pituitary GnRH receptors. 7.2 Drug-Laboratory Test Interactions Administration of TRIPTODUR results in suppression of the pituitary-gonadal system. The effect of TRIPTODUR on pituitary and gonadal function is expected to disappear within six to twelve months after treatment discontinuation.
Warnings
5 WARNINGS AND PRECAUTIONS Initial Rise of Gonadotropins and Sex Steroid Levels: An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. ( 5.1 ) Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. 4 CONTRAINDICATIONS Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH [see Adverse Reactions (6.2) ] . Pregnancy: TRIPTODUR may cause fetal harm [see Use in Specific Populations (8.1) ] . Hypersensitivity reactions ( 4 ) Pregnancy ( 4 , 8.1 )
Pregnancy
8.1 Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [ see Contraindications ( 4 ) ] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss. Available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, TRIPTODUR may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Each TRIPTODUR 22.5 mg single-use kit (NDC 24338-150-20) contains: One single-dose vial of TRIPTODUR 22.5 mg (NDC 24338-150-01) with a Flip-Off seal containing sterile lyophilized white to slightly yellow powder cake One sterile, glass syringe with Luer Lock prefilled with 2 mL of Sterile Water for Injection (NDC 24338-150-02) Two sterile 21 gauge, 1½" needles...
Frequently Asked Questions
What is Triptorelin used for?▼
1 INDICATIONS AND USAGE TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty. ( 1 )
What are the side effects of Triptorelin?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial Rise of Gonadotropins and Sex Steroid Levels [ see Warnings and Precautions ( 5.1 ) ] Psychiatric Events [ see Warnings and Precautions ( 5.2 ) ] Convulsions [ see Warnings and Precautions ( 5.3 ) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.4 ) ] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 ) ] In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infec...
Can I take Triptorelin during pregnancy?▼
8.1 Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [ see Contraindications ( 4 ) ] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss. Available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, TRIPTODUR may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus.
What are the important warnings for Triptorelin?▼
5 WARNINGS AND PRECAUTIONS Initial Rise of Gonadotropins and Sex Steroid Levels: An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. ( 5.1 ) Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. 4 CONTRAINDICATIONS Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH [see Adverse Reactions (6.2) ] . Pregnancy: TRIPTODUR may cause fetal harm [see Use in Specific Populations (8.1) ] . Hypersensitivity reactions ( 4 ) Pregnancy ( 4 , 8.1 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.