Dynacin

Name: Dynacin

Do I need a prescription for minocycline-oral?

Yes

Side Effects of Dynacin

Minocycline may cause serious side effects. See "Drug Precautions" section.

The most common side effects of minocycline include:

  • nausea
  • fever
  • diarrhea
  • vomiting
  • headache
  • tiredness
  • dizziness or spinning feeling
  • itching

Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with minocycline.

These are not all the side effects with minocycline. Ask your doctor or pharmacist for more information.

Dynacin Interactions

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Minocycline may affect the way other medicines work, and other medicines may affect how minocycline works.

Especially tell your doctor if you take:

  • birth control pills. Minocycline may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline.
  • a blood thinner medicine.
  • a penicillin antibiotic medicine. Minocycline and penicillins should not be used together.
  • antacids that contain aluminum, calcium, or magnesium or iron-containing products.
  • an acne medicine that contains isotretinoin (Amnesteem, Claravis, Sotret). Minocycline and isotretinoin should not be used together.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

Dynacin and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. Minocycline may harm your unborn baby. Taking minocycline while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking minocycline if you plan to become pregnant, or if you are already taking minocycline and plan to become pregnant. Stop taking minocycline and call your doctor right away if you become pregnant while taking minocycline.

Minocycline may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline.

If you are a male, and you and your female partner are trying to conceive a baby. You should not take minocycline.

What is the most important information I should know about Dynacin (minocycline)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

How should I take Dynacin (minocycline)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

You may take minocycline with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Minocycline will not treat a viral infection such as the flu or a common cold.

If you use this medicine long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using minocycline.

Store at room temperature away from moisture, heat, and light.

Throw away any minocycline not used before the expiration date on the medicine label. Using expired minocycline can cause damage to your kidneys.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, nausea, or vomiting.

Before Using Dynacin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of minocycline extended-release capsules and tablets in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

Minocycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children younger than 8 years of age unless directed by the child's doctor.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of minocycline in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving minocycline.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amoxicillin
  • Ampicillin
  • Atazanavir
  • Bacampicillin
  • Bexarotene
  • Cholera Vaccine, Live
  • Cloxacillin
  • Dicloxacillin
  • Digoxin
  • Etretinate
  • Isotretinoin
  • Methicillin
  • Methoxyflurane
  • Nafcillin
  • Oxacillin
  • Penicillin G
  • Penicillin G Benzathine
  • Penicillin G Procaine
  • Penicillin V
  • Piperacillin
  • Pivampicillin
  • Sultamicillin
  • Temocillin
  • Tretinoin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Aminolevulinic Acid
  • Calcium
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Iron
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Vitamin A

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea or
  • Increased pressure in the head or
  • Infection (eg, fungi), any other type of or
  • Liver disease—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Dynacin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blurred or double vision
  • bulging soft spot on the head of an infant
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • confusion
  • diarrhea
  • dizziness or lightheadedness
  • eye pain
  • fast heartbeat
  • general feeling of discomfort or illness
  • general tiredness and weakness
  • hives, itching, or skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea or vomiting
  • red skin lesions, often with a purple center
  • severe headache
  • severe stomach pain
  • sores, ulcers, or white spots on the lips or in the mouth
  • troubled breathing
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty with moving
  • hearing loss
  • hives or welts
  • muscle stiffness
  • redness of the skin
  • sleepiness or unusual drowsiness
Incidence not known
  • Bloating
  • discoloration of the tooth
  • increased sensitivity of the skin to sunlight
  • indigestion
  • severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dynacin Description

Minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 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:

C23H27N3O7 ·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: Microcrystalline Cellulose NF, Lactose Anhydrous NF, Povidone USP, Colloidal Silicon Dioxide NF, Magnesium Stearate NF, and Sodium Starch Glycolate NF. The 50 mg, 75 mg and 100 mg tablets also contain Opadry White which contains: Titanium Dioxide USP, Hypromellose Type 2910 USP, Polyethylene Glycol 400 NF, and Polysorbate 80 NF.

Contraindications

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

Precautions

General: As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible 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 headache 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.

Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.

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

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

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 with use of minocycline.

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

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

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.

Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

Laboratory Tests

In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.

Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic, should be performed.

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 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.

Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see PRECAUTIONS).

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

Drug and/or Laboratory Test Interactions

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

Carcinogenesis and Mutagenesis and 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 in vitro 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

Teratogenic Effects: Pregnancy Category D (see WARNINGS).

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Nonteratogenic Effects: (see WARNINGS).

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 WARNINGS).

Pediatric Use

Minocycline is not recommended for use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS).

Geriatric Use

Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS, DOSAGE AND ADMINISTRATION).

Principal display panel - 100mg tablets

Dynacin 
minocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-096
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
ANHYDROUS LACTOSE  
POVIDONES  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
HYPROMELLOSES  
Product Characteristics
Color white Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code Par;511
Contains     
Packaging
# Item Code Package Description
1 NDC:49884-096-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065131 06/20/2011
Dynacin 
minocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-097
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
ANHYDROUS LACTOSE  
POVIDONES  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
HYPROMELLOSES  
Product Characteristics
Color white Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code Par;512
Contains     
Packaging
# Item Code Package Description
1 NDC:49884-097-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065131 06/20/2011
Dynacin 
minocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-098
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE) MINOCYCLINE 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
ANHYDROUS LACTOSE  
POVIDONES  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 400  
POLYSORBATE 80  
HYPROMELLOSES  
Product Characteristics
Color white Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code Par;513
Contains     
Packaging
# Item Code Package Description
1 NDC:49884-098-03 50 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065131 06/20/2011
Labeler - Par Pharmaceutical, Inc. (092733690)
Registrant - Par Pharmaceutical, Inc. (092733690)
Establishment
Name Address ID/FEI Operations
Par Pharmaceutical, Inc. 092733690 MANUFACTURE(49884-096, 49884-097, 49884-098)
Revised: 12/2014   Par Pharmaceutical, Inc.
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