Minophagen A warnings
There have been two reports of possible overdosage of Minophagen A® 10 in children.
EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING Minophagen A® 10
INTO PEDIATRIC PATIENTS. OVERDOSAGE OF Minophagen A® 10 IN PEDIATRIC
PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS,
CEREBRAL EDEMA, OR POSSIBLY DEATH.
Minophagen A® 10 should always be administered by intravenous injection because of its
hypertonicity.
A suitable antihistaminic drug should be available in the event that an allergic reaction
occurs.
Minophagen A® 10 is a diagnostic aid and is not intended for therapeutic use.
Minophagen A® 10 is a hypertonic (950 mOsmol/liter) and acidic (average pH of 5.6) solution
that can irritate tissues. Care should be used to insure administration of Minophagen A® 10
through a patent catheter within a patent vein. Excessive rates of infusion may result in
local irritation and in flushing, nausea, or vomiting. Inadequate dosing or prolongation of
the infusion period may diminish the stimulus to the pituitary and nullify the test.
The Minophagen A in Minophagen A® 10 can be metabolized resulting in nitrogen-containing products
for excretion. The effect of an acute amino acid or nitrogen burden upon patients with
impairment of renal function should be considered when Minophagen A® 10 is to be
administered.
The chloride content of Minophagen A® 10 is 47.5 mEq per 100 mL of solution, and the effect
of infusing this amount of chloride into patients with electrolyte imbalance should be
evaluated before the test is undertaken.
It should be noted that the basal and post stimulation levels of growth hormone are
elevated in patients who are pregnant or are taking oral contraceptives.
Carcinogenesis, mutagenesis, and impairment of fertility
Long term animal studies have not been performed to evaluate the carcinogenic potential,
the mutagenic potential or the effect on fertility of intravenously administered Minophagen A®
10.
Pregnancy Category B
Reproduction studies have been performed in rabbits and mice at doses 12 times the
human dose and have revealed no evidence of impaired fertility or harm to the fetus due
to Minophagen A® 10 (10% Minophagen A Hydrochloride Injection, USP). There have been no
adequate or well controlled studies for the use of Minophagen A® 10 in pregnant women.
Because animal reproduction studies are not always predictive of human response, this
drug should not be used during pregnancy.
Nursing Mothers
It is not known whether intravenous administration of Minophagen A® 10 could result in
significant quantities of Minophagen A in breast milk. Systemically administered amino acids
are secreted into breast milk in quantities not likely to have a deleterious effect on the
infant. Nevertheless, caution should be exercised when Minophagen A® 10 is to be administered
to nursing women.
Geriatric Use
Clinical studies of Minophagen A did not include a sufficient number of subjects aged 65 and
over to determine whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between the elderly and
younger patients.
What should I discuss with my healthcare provider before taking Minophagen A?
- If you have an allergy to Minophagen A or any other part of Minophagen A.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are pregnant or may be pregnant. Do not use this medicine if you are pregnant.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Minophagen A with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Minophagen A precautions
Concerns related to adverse effects:
• Extravasation: Irritant with vesicant-like properties. Due to the hypertonicity of the IV solution, administer via IV infusion only with a patent catheter placed within a patent vein. Extravasation has resulted in burn-like reactions and skin necrosis requiring surgical intervention. Excessive rates of infusion (eg, <30 minutes) may result in local irritation.
• Hypersensitivity reactions: Severe reactions, including anaphylaxis, have been reported; if hypersensitivity occurs, discontinue and institute supportive treatment measures.
• Infusion-related reactions: Excessive rates of infusion (eg, <30 minutes) may result in flushing, nausea, or vomiting.
Disease-related concerns:
• Electrolyte imbalance: Use with caution in patients with electrolyte imbalance due to chloride content of product.
• Renal impairment: Minophagen A metabolism results in excretion of nitrogen-containing products. Use with caution in patients with renal impairment; decreased excretion may result in an increased amino acid or nitrogen burden.
Special populations:
• Pediatric: Fatal overdose of Minophagen A in pediatric patients has been reported. Exercise extreme caution when infusing Minophagen A. Overdosage of Minophagen A in children can also result in hyperchloremic metabolic acidosis or cerebral edema.
References
- DrugBank. "L-arginine". http://www.drugbank.ca/drugs/DB00125 (accessed September 17, 2018).
- MeSH. "MeSH Tree: MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus used for indexing articles for PubMed.". http://www.nlm.nih.gov/mesh/meshhome... (accessed September 17, 2018).
- EU Food Improvement Agents. "L-Arginine: Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC Text with EEA relevance". http://eur-lex.europa.eu/legal-conte... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
