Minocycline Hydrochloride

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Overview

What is Minocycline Hydrochloride?

Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy- 1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:

CHNO•HCL M.W. 493.94

Minocycline hydrochloride tablets for oral administration contain minocycline HCl equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, 50 mg, 75 mg and 100 mg tablets contain the following inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone and Sodium Starch Glycolate.

The 50 mg tablets also contain Opadry Yellow which contains: FD&C Blue No. 2, FD&C Yellow No. 5, Titanium Dioxide, Hypromellose, Polyethylene Glycol.The 75 mg and 100 mg tablets contain Opadry Gray which contains: Titanium Dioxide, Hypromellose, Polyethylene Glycol, Polysorbate 80 and Iron Oxide Black. Minocycline Hydrochloride Tablets, 50 mg contains FD&C Yellow No. 5 (Tartrazine) as color additive.

What does Minocycline Hydrochloride look like?

What are the available doses of Minocycline Hydrochloride?

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

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How should I use Minocycline Hydrochloride?

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What interacts with Minocycline Hydrochloride?

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

What are the warnings of Minocycline Hydrochloride?

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against

MINOCYCLINE HYDROCHLORIDE TABLETS, LIKE OTHER TETRACYCLINES-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline.

Central nervous system side effects including light headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

What are the precautions of Minocycline Hydrochloride?

Minocycline Hydrochloride Tablets, 50 mg contains FD&C Yellow No. 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (Tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

General

As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.

Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headaches and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.

Prescribing minocycline hydrochloride tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.

Information For Patients

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported rarely with use of minocycline.

Patients who experience central nervous system symptoms (see ) should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.

Concurrent use of tetracycline may render oral contraceptives less effective (see ).

Patients should be counseled that antibacterial drugs, including minocycline hydrochloride tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride tablets are prescribed to treat a bacterial infection, patients should be told that, although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride tablets or other antibacterial drugs in the future.

Laboratory Tests

In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with minocycline should have a follow-up serologic test for syphilis after 3 months.

Drug Interactions

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Absorption of oral tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

Drug Laboratory Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary administration of minocycline in long term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats.

Pregnancy

Pregnancy Category D

(See ).

(See ).

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see ).

Pediatric Use

(See ).

What are the side effects of Minocycline Hydrochloride?

Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and increases in liver enzymes have been reported. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see ).

Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions have been rarely reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see ). Pigmentation of the skin and mucous membranes has been reported.

Renal toxicity: Elevations in BUN have been reported and are apparently dose related (see ). Acute renal failure has been rarely reported and, in most cases, has been reversible.

Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A lupus-like syndrome and serum sickness-like reactions have also been reported.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Central nervous system: Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults (see ) have been reported. Headache has also been reported.

Other: When given over prolonged periods, tetracyclines have been reported to produce brownblack microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration in pediatric patients less than 8 years of age (see ) and also, rarely, in adults have been reported.

Tinnitus and decreased hearing has been rarely reported in patients on minocycline hydrochloride.

What should I look out for while using Minocycline Hydrochloride?

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What might happen if I take too much Minocycline Hydrochloride?

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

How should I store and handle Minocycline Hydrochloride?

Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayMinocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 100 mg, 75 mg and 50 mg minocycline. The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I-73” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: (NDC 24724-003-05) Bottle of 50 (NDC 24724-003-10) Bottle of 1000The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I-72” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: (NDC 24724-002-01) Bottle of 100 (NDC 24724-002-10) Bottle of 1000The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I-71” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: (NDC 24724-001-01) Bottle of 100 (NDC 24724-001-10) Bottle of 1000Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Protect from light, moisture and excessive heat.Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 100 mg, 75 mg and 50 mg minocycline. The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I-73” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: (NDC 24724-003-05) Bottle of 50 (NDC 24724-003-10) Bottle of 1000The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I-72” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: (NDC 24724-002-01) Bottle of 100 (NDC 24724-002-10) Bottle of 1000The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I-71” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: (NDC 24724-001-01) Bottle of 100 (NDC 24724-001-10) Bottle of 1000Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Protect from light, moisture and excessive heat.Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 100 mg, 75 mg and 50 mg minocycline. The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I-73” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: (NDC 24724-003-05) Bottle of 50 (NDC 24724-003-10) Bottle of 1000The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I-72” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: (NDC 24724-002-01) Bottle of 100 (NDC 24724-002-10) Bottle of 1000The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I-71” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: (NDC 24724-001-01) Bottle of 100 (NDC 24724-001-10) Bottle of 1000Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Protect from light, moisture and excessive heat.Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 100 mg, 75 mg and 50 mg minocycline. The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I-73” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: (NDC 24724-003-05) Bottle of 50 (NDC 24724-003-10) Bottle of 1000The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I-72” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: (NDC 24724-002-01) Bottle of 100 (NDC 24724-002-10) Bottle of 1000The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I-71” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: (NDC 24724-001-01) Bottle of 100 (NDC 24724-001-10) Bottle of 1000Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Protect from light, moisture and excessive heat.Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 100 mg, 75 mg and 50 mg minocycline. The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I-73” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: (NDC 24724-003-05) Bottle of 50 (NDC 24724-003-10) Bottle of 1000The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I-72” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: (NDC 24724-002-01) Bottle of 100 (NDC 24724-002-10) Bottle of 1000The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I-71” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: (NDC 24724-001-01) Bottle of 100 (NDC 24724-001-10) Bottle of 1000Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Protect from light, moisture and excessive heat.

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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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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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