Solodyn

DRUG DESCRIPTION

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S (4?,4a?,5a?,12a?)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below:

SOLODYN®
  (minocycline HCl) Structural Formula Illustration

C23H27N3O7•HCl.........................M. W. 493.95

SOLODYN® Tablets for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg of minocycline. In addition, 45 mg, 65 mg, 90 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain Opadry II Gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain Opadry II Yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2. The 135 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.

What are the possible side effects of minocycline (Dynacin, Minocin, Minocin PAC, Myrac, Solodyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using minocycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or...

Read All Potential Side Effects and See Pictures of Solodyn »

What are the precautions when taking minocycline hydrochloride (Solodyn)?

Before taking minocycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., doxycycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), lupus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and...

Read All Potential Precautions of Solodyn »


Solodyn Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, lightheadedness, dizziness, unsteadiness, drowsiness, mild headache, mouth sores, or cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), muscle pain, difficult/painful swallowing, change in the amount of urine, pink urine, brown/gray tooth discoloration, blue/gray/brown discoloration of the skin/lips/tongue/gums, numbness/tingling of the hands/feet, unusual tiredness, new signs of infection (e.g., fever, chills, persistent sore throat).

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, unusual/severe headache, vision changes (e.g., blurred vision).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (fungal infections). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, swollen glands, chest pain, fast/irregular heartbeat, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking minocycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., doxycycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), lupus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using minocycline.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. It should not be used in women or men trying to have a child. Women of child-bearing age and men should use effective birth control while taking this medication. Consult your doctor for more details. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Solodyn Patient Information Including Side Effects

Brand Names: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Generic Name: minocycline (Pronunciation: mye no SYE kleen)

  • What is minocycline (Solodyn)?
  • What are the possible side effects of minocycline (Solodyn)?
  • What is the most important information I should know about minocycline (Solodyn)?
  • What should I discuss with my healthcare provider before taking minocycline (Solodyn)?
  • How should I take minocycline (Solodyn)?
  • What happens if I miss a dose (Solodyn)?
  • What happens if I overdose (Solodyn)?
  • What should I avoid while taking minocycline (Solodyn)?
  • What other drugs will affect minocycline (Solodyn)?
  • Where can I get more information?

What is minocycline (Solodyn)?

Minocycline is a tetracycline antibiotic. It fights bacteria in the body.

Minocycline is used to treat many different bacterial infections, such as urinary tract infections, severe acne, gonorrhea, tick fever, chlamydia, and others.

Minocycline may also be used for other purposes not listed in this medication guide.

What are the possible side effects of minocycline (Solodyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using minocycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, jaundice (yellowing of the skin or eyes); or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • sores or swelling in your rectal or genital area;
  • mild nausea, vomiting, diarrhea, or stomach upset;
  • white patches or sores inside your mouth or on your lips;
  • swollen tongue, trouble swallowing; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

Do not use this medication if you are pregnant. It could cause harm to the unborn baby, including permanent discoloration of the teeth later in life. Minocycline can make birth control pills less effective. Use a second method of birth control while you are taking minoocycline to keep from getting pregnant.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not give minocycline to a child younger than 8 years old. Minocycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Minocycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking minocycline. These products can make minocycline less effective.

Throw away any unused minocycline when it expires or when it is no longer needed. Do not take any minocycline after the expiration date printed on the label. Using expired minocycline can cause damage to your kidneys.

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