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| Product NDC Code | 67457-134 | ||||
|---|---|---|---|---|---|
| Drug Name | Magnesium chloride |
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| Type | Generic | ||||
| Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | INTRAVENOUS | ||||
| Dosage Form | INJECTION | ||||
| RxCUI drug identifier | 311422 | ||||
| Labeler Name | Mylan Institutional LLC | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately respiratory depression.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection, q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2.951 mOsm/mL. Contains 1.97 mEq of Mg ++ and Cl - per mL. The structural formula is MgCl 2 •6H 2 O
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION For intravenous infusion: 4 grams in 250 mL of 5% Dextrose Injection, at a rate not exceeding 3 mL per minute. Serum magnesium levels should serve as a guide to continued dosage.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS As an electrolyte replenisher in magnesium deficiencies.
Spl product data elements
Usually a list of ingredients in a drug product.Magnesium Chloride magnesium chloride MAGNESIUM CHLORIDE MAGNESIUM CATION SODIUM CHLORIDE BENZYL ALCOHOL WATER HYDROCHLORIC ACID SODIUM HYDROXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 200 mg/mL NDC 67457-134-50 50 mL Magnesium Chloride Injection 200 mg/mL (20% w/v) 2.951 mOsm/mL For Intravenous Use After Dilution Rx only Multiple-Dose Vial Each mL contains: Magnesium Chloride Hexahydrate 200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2.951 mOsm/mL. Contains 1.97 mEq of Mg ++ and CI¯ per mL. WARNING: DO NOT USE IF A PRECIPITATE IS PRESENT. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Usual Dosage: See accompanying prescribing information. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland MI:134:1C:R5 Mylan.com Magnesium Chloride Injection 200 mg/mL Carton Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.ACTIONS Magnesium is the second most plentiful cation within cellular fluids. It is an important activator of many enzyme systems and deficits are accompanied by a variety of functional disturbances.
USUAL DOSAGE RANGE 1 to 40 grams daily. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Animal reproduction studies have not been conducted with magnesium chloride. It is also not known whether magnesium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium Chloride should be given to a pregnant woman only if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Magnesium Chloride Injection 200 mg/mL (20% w/v). NDC 67457-134-50 50 mL Multiple-Dose Vial. Individually boxed. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 Manufactured by: Mylan Institutional Galway, Ireland 1084L101 Revised: 10/2021 MI:MAGNIJ:R4
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS The usual precautions for parenteral administration should be observed. Administer with caution if flushing and sweating occurs. A preparation of a calcium salt should be readily available for intravenous injection to counteract potential serious signs of magnesium intoxication. As long as deep tendon reflexes are active it is probable that the patient will not develop respiratory paralysis. Respiration and blood pressure should be carefully observed during and after administration of Magnesium Chloride Injection. Pregnancy Animal reproduction studies have not been conducted with magnesium chloride. It is also not known whether magnesium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium Chloride should be given to a pregnant woman only if clearly needed.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNING Do not use if a precipitate is present.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API