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HUMATROPE

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Overview

What is HUMATROPE?

Humatrope (somatropin, rDNA origin, for injection) is a polypeptide hormone of recombinant DNA origin. Humatrope is synthesized in a strain of Escherichia coli that has been modified by the addition of the gene for human GH. The peptide is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence of the peptide is identical to that of human GH of pituitary origin.

Humatrope is a sterile, white, lyophilized powder intended for subcutaneous or intramuscular administration after reconstitution to its liquid form. Humatrope is a highly purified preparation. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive.



What does HUMATROPE look like?



What are the available doses of HUMATROPE?

Humatrope is a sterile, white lyophilized powder available in the following vial and cartridge sizes:

Humatrope cartridges should be used only with the appropriate corresponding pen device.

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

How should I use HUMATROPE?

Humatrope is a recombinant human growth hormone (somatropin) indicated for:

For subcutaneous injection.

Therapy with Humatrope should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GH deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, small for gestational age birth, or adult patients with either childhood-onset or adult-onset GH deficiency.


What interacts with HUMATROPE?

Sorry No Records found


What are the warnings of HUMATROPE?

Sorry No Records found


What are the precautions of HUMATROPE?

Sorry No Records found


What are the side effects of HUMATROPE?

Sorry No records found


What should I look out for while using HUMATROPE?

Acute critical illness. ()

Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death. ()

Active malignancy. ()

Hypersensitivity to somatropin or excipients. ()

Active proliferative or severe non-proliferative diabetic retinopathy. ()

Children with closed epiphyses. ()


What might happen if I take too much HUMATROPE?


How should I store and handle HUMATROPE?

Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016Methylphenidate Hydrochloride Tablets, USP are available as follows:DAN 5 5882 DAN 10 5883 DAN 20 5884 Protect from light.Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.Do not store above 30°C (86°F).Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2016


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Clinical Information

Chemical Structure

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Clinical Pharmacology

GH binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-I, IGF BP-3 and acid-labile subunit. GH has direct tissue and metabolic effects, including stimulation of chondrocyte differentiation, stimulation of lipolysis and stimulation of hepatic glucose output. In addition, some effects of somatropin are mediated indirectly by IGF-I, including stimulation of protein synthesis and chondrocyte proliferation.

Non-Clinical Toxicology
Acute critical illness. ()

Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death. ()

Active malignancy. ()

Hypersensitivity to somatropin or excipients. ()

Active proliferative or severe non-proliferative diabetic retinopathy. ()

Children with closed epiphyses. ()

Methylphenidate should not be used in patients being treated (currently or within the proceeding two weeks) with MAO Inhibitors (see ). Because of possible effects on blood pressure, methylphenidate should be used cautiously with pressor agents.

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Methylphenidate is metabolized primarily to ritalinic acid by de-esterification and not through oxidative pathways.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin . Two placebo-controlled clinical trials in non-GH deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8.0 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk.

The following important adverse reactions are also described elsewhere in the labeling:

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).