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Trelstar

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Overview

What is Trelstar?

TRELSTAR is a white to slightly yellow lyophilized cake.  When reconstituted, TRELSTAR has a milky appearance.  It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). 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).  The empirical formula is CHNO · CHO and the molecular weight is 1699.9. The structural formula is:

Structural formula for TRELSTAR (triptorelin pamoate).

The TRELSTAR products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials.  Refer to Table 5 for the composition of each TRELSTAR product.

When 2 mL sterile water is added to the vial containing TRELSTAR and mixed, a suspension is formed which is intended as an intramuscular injection.  TRELSTAR is available in two packaging configurations: (a) TRELSTAR vial alone or (b) TRELSTAR vial plus a MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to 8.5.



What does Trelstar look like?



What are the available doses of Trelstar?

Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg.  ()

What should I talk to my health care provider before I take Trelstar?

How should I use Trelstar?

TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [ ].

3.75 mg every 4 weeks.  ()

11.25 mg every 12 weeks.  ()

22.5 mg every 24 weeks.  ()


What interacts with Trelstar?

Sorry No Records found


What are the warnings of Trelstar?

Sorry No Records found


What are the precautions of Trelstar?

Sorry No Records found


What are the side effects of Trelstar?

Sorry No records found


What should I look out for while using Trelstar?

Known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.  ()

Pregnancy.  ( and )


What might happen if I take too much Trelstar?

There is no experience of overdosage in clinical trials.  In single dose toxicity studies in mice and rats, the subcutaneous LD of triptorelin was 400 mg/kg in mice and 250 mg/kg in rats, approximately 500 and 600 times, respectively, the estimated monthly human dose based on body surface area.  If overdosage occurs, therapy should be discontinued immediately and the appropriate supportive and symptomatic treatment administered.


How should I store and handle Trelstar?

Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.TRELSTAR 3.75 mgTRELSTAR 11.25 mgTRELSTAR 22.5 mgStorageTRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.TRELSTAR 3.75 mgTRELSTAR 11.25 mgTRELSTAR 22.5 mgStorageTRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.TRELSTAR 3.75 mgTRELSTAR 11.25 mgTRELSTAR 22.5 mgStorageTRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.TRELSTAR 3.75 mgTRELSTAR 11.25 mgTRELSTAR 22.5 mgStorageTRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.TRELSTAR 3.75 mgTRELSTAR 11.25 mgTRELSTAR 22.5 mgStorage


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Triptorelin is a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH).  Comparative studies showed that triptorelin was 100-fold more active than native GnRH in stimulating luteinizing hormone release from monolayers of dispersed rat pituitary cells in culture and 20-fold more active than native GnRH in displacing I-GnRH from pituitary receptor sites.  In animal studies, triptorelin pamoate was found to have 13‑fold higher luteinizing hormone-releasing activity and 21-fold higher follicle-stimulating hormone-releasing activity compared to the native GnRH.

Non-Clinical Toxicology
Known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.  ()

Pregnancy.  ( and )

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride (see ).

As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported.  In the event of a hypersensitivity reaction, therapy with TRELSTAR should be discontinued immediately and the appropriate supportive and symptomatic care should be administered. 

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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