Solodyn minocycline hydrochloride

Get an overview of SOLODYN (minocycline hydrochloride tablet, film coated, extended release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Solodyn can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Solodyn.

Drug Basics

Brand Name: Solodyn

Generic Name: MINOCYCLINE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE

Data Current As Of: 2019-06-10

indications & usage

SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1)

indication

SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

limitations of use

SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)].

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN should be used only as indicated [see Warnings and Precautions (5.11)].

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients taking SOLODYN (minocycline HCl, USP) Extended Release Tablets should receive the following information and instructions:

  • SOLODYN should not be used by pregnant women or women attempting to conceive a child [see Use in Specific Populations (8.1) and Nonclinical Toxicology (13.1)].
  • It is recommended that SOLODYN not be used by men who are attempting to father a child [see Nonclinical Toxicology (13.1)].
  • Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention.
  • Patients should be counseled about the possibility of hepatotoxicity. Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness.
  • Patients who experience central nervous system symptoms [see Warnings and Precautions (5.5)] should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should seek medical help for persistent headaches or blurred vision.
  • Concurrent use of tetracycline may render oral contraceptives less effective [see Drug Interactions (7.5)].
  • Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash, and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
  • Patients should be counseled about discoloration of skin, scars, teeth, or gums that can arise from minocycline therapy.
  • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (i.e., tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema.
  • SOLODYN should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.
  • Patients should be advised to swallow SOLODYN Tablets whole and not to chew, crush, or split the tablets.
  •   Distributed by:
    Valeant Pharmaceuticals North America LLC
    Bridgewater, NJ 08807 USA
  •  U.S. Patent Numbers: 5,908,838; 7,790,705; 7,919,483; 8,252,776; 8,268,804; 8,722,650 and 9,192,615
  •  ®/™ are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.
  •  ©Valeant Pharmaceuticals North America LLC
  •  Rev. 09/2017
    9387304 N4605J

Patient Information
SOLODYN® (SO-lo-dīn)
(minocycline HCl)
Extended Release Tablets

Read this Patient Information leaflet that comes with SOLODYN before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is SOLODYN?

SOLODYN is a tetracycline-class drug. SOLODYN is prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older. SOLODYN is not effective for acne that is not red-looking (this means acne that is not inflammatory).

It is not known if SOLODYN is:

  • safe for use longer than 12 weeks.
  • safe and effective for the treatment of infections.
  • safe and effective in children under the age of 12 years.

Who should not take SOLODYN?

Do not take SOLODYN if you are allergic to tetracycline-class drugs. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

What should I tell my doctor before taking SOLODYN?

Before you take SOLODYN, tell your doctor if you:

  • have kidney problems. Your doctor may prescribe a lower dose of medicine for you.
  • have liver problems.
  • have diarrhea or watery stools.
  • have vision problems.
  • plan to have surgery with general anesthesia.
  • have any other medical conditions.
  • are a male, and you and your female partner are trying to conceive a baby. You should not take SOLODYN.
  • are pregnant or plan to become pregnant. SOLODYN may harm your unborn baby. Taking SOLODYN 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 SOLODYN if you plan to become pregnant or if you are already taking SOLODYN and plan to become pregnant. Stop taking SOLODYN and call your doctor right away if you become pregnant while taking SOLODYN.
  • are breastfeeding or plan to breastfeed. SOLODYN passes into your milk and may harm your baby. You and your doctor should decide if you will take SOLODYN or breastfeed. You should not do both.

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

Especially tell your doctor if you take:

  • birth control pills. SOLODYNmay make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking SOLODYN.
  • a blood thinner medicine.
  • a penicillin antibiotic medicine. SOLODYNand 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). SOLODYN 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.

How should I take SOLODYN?

  • Take SOLODYN exactly as your doctor tells you.
  • Skipping doses or not taking all doses of SOLODYN may:
    • make the treatment not work as well.
    • increase the chance that the bacteria will become resistant to SOLODYN.
  • SOLODYN can be taken with or without food. Taking SOLODYN with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
  • Swallow SOLODYN Tablets whole. Do not chew, crush, or split the tablets.

If you take too much SOLODYN, call your doctor or poison control center right away. Your doctor may do blood tests to check you for side effects during treatment with SOLODYN.

What should I avoid while taking SOLODYN?

  • Avoid sunlight, sunlamps, and tanning beds. SOLODYN can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn.
  • Protect your skin while out in sunlight.
  • You should not drive or operate dangerous machinery until you know how SOLODYN affects you. SOLODYN may cause you to feel dizzy or light-headed, or have a spinning feeling (vertigo).

What are possible side effects of SOLODYN?

SOLODYN may cause serious side effects, including:

  • Harm to an unborn baby. See "What should I tell my doctor before taking SOLODYN?"
  • Permanent teeth discoloration. SOLODYN may permanently turn a baby’s or child's teeth yellow-grey-brown during tooth development. SOLODYN should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See "What should I tell my doctor before taking SOLODYN?"
  • Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including SOLODYN. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.
  • Serious liver problems. Stop taking SOLODYN and call your doctor right away if you get any of the following symptoms of liver problems:
    • loss of appetite
    • tiredness
    • diarrhea
    • yellowing of your skin or the whites of your eyes
    • unexplained bleeding
    • confusion
    • sleepiness
  • Central nervous system effects. See "What should I avoid while taking SOLODYN?" Central nervous system effects such as light-headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with SOLODYN or if treatment is stopped.
  • Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking SOLODYN and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.
  • Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Using SOLODYN for a long time to treat acne may cause immune system reactions. Tell your doctor right away if you get a fever, rash, joint pain, or body weakness. Your doctor may do tests to check your blood for immune system reactions.
  • Serious rash and allergic reactions. SOLODYN may cause a serious rash and allergic reactions that may affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these can lead to death.
  • Stop taking SOLODYN and get medical help right away if you have any of these symptoms:
    • skin rash, hives, sores in your mouth, or your skin blisters and peels
    • swelling of your face, eyes, lips, tongue, or throat
    • trouble swallowing or breathing
    • blood in your urine
    • fever, yellowing of the skin or the whites of your eyes, dark colored urine
    • pain on the right side of the stomach area (abdominal pain)
    • chest pain or abnormal heartbeats
    • swelling in your legs, ankles, and feet
    • darkening of your nails, skin, eyes, scars, teeth, and gums

The most common side effects of SOLODYN include:

  • 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 SOLODYN.

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Valeant Pharmaceuticals North America LLC at 1-800-321-4576.

How should I store SOLODYN?

  • Store SOLODYN between 59°F to 86°F (15°C to 30°C).
  • Keep SOLODYN Tablets in the container that it comes in and keep the container tightly closed.
  • Keep SOLODYN Tablets dry.

Keep SOLODYN and all medicines out of the reach of children.

General information about SOLODYN

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use SOLODYN for a condition for which it was not prescribed. Do not give SOLODYN to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about SOLODYN. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SOLODYN that is written for health professionals.

For more information, call 1-800-321-4576.

What are the ingredients in SOLODYN?

Active ingredient: minocycline HCl.

Inactive ingredients: lactose monohydrate, hypromellose type 2910, magnesium stearate, colloidal silicon dioxide, and carnauba wax.

The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910, titanium dioxide, lactose monohydrate, polyethylene glycol 3350, triacetin, and FD&C Red #40.

The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910, lactose monohydrate, FD&C Blue #1, polyethylene glycol 3350, FD&C Blue #2, titanium dioxide, triacetin, and D&C Yellow #10.

The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910, lactose monohydrate, polyethylene glycol 3350, FD&C Blue #2, FD&C Red #40, titanium dioxide, triacetin, and FD&C Yellow #6.

The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910, lactose monohydrate, titanium dioxide, D&C Red #27, polyethylene glycol 3350, triacetin, and FD&C Blue #1.

The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910, lactose monohydrate NF, D&C Yellow #10, triacetin, FD&C Blue #1, titanium dioxide, and FD&C Blue #2.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

U.S. Patent Numbers: 5,908,838; 7,790,705; 7,919,483; 8,252,776; 8,268,804; 8,722,650 and 9,192,615

®/™ are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

Rev. 09/17

9387304 N4605J

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Search Drugs and Medication

Or Browse by Name

Top Reads
  • Learn about drugs going generic in 2021 and how you may be able to save money on common prescription medication by switching to drugs coming off-patent.
    November 20, 2019
  • To make sure your medicines work as they should, here are some of the most common food-and-drug combinations to avoid.
    October 22, 2015
  • Get a list of the top 50 prescription drugs out of the annual 3 billion prescriptions filled at U.S. pharmacies.
    September 5, 2019
  • While medications are extremely useful in treating various diseases and conditions, sometimes they can cause unwanted side effects—one of which can be sexual dysfunction. Talk to your doctor if you’re taking any of these common medications that affect sex drive.
    September 23, 2016
  • Here’s a look at the most commonly abused prescription drugs.
    October 30, 2014

Love the Doctor Who Prescribed This Medication?

Top Drugs
  • Digestive health drugs manage diseases, disorders and conditions of the gastrointesinal system. They provide treatment and symptom relief for functional and structural problems with digestive organs.
  • Antibiotic, antifungal and antiviral drugs treat infectious diseases. They kill or stop the growth of microorganisms, including bacteria, fungi and viruses.
  • Birth control medications are a form of contraception. They contain either a combination of estrogen and progestin or progestin alone. There are several forms of these hormones, but most combination products contain estrogen, ethinyl estradiol, and a progestin. They work by preventing ovulation and inhibiting fertilization and implantation.
  • Mental health drugs treat conditions that affect emotional, psychological and social well-being. Doctors frequently use mental health drugs in combination with various forms of therapy to help people manage these conditions.