Minocycline ER 45mg Tablets

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the binding of aminoacyl tRNA to the mRNA-ribosome complex. This leads to bacteriostatic effects. Its anti-inflammatory properties, which are beneficial in acne, are thought to be due to inhibition of neutrophil chemotaxis, lipase activity, and pro-inflammatory cytokine production.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Changes in hearing
Joint pain or swelling
Muscle pain or weakness
Ringing in the ears
Seizures
Shortness of breath
Chest pain
Abnormal heartbeat
Swelling
Changes in nail, skin, eye, scar, tooth, or gum color to a darker shade
Mouth irritation or sores
Burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
Rectal or genital irritation
Vaginal itching or discharge
Diarrhea (common with antibiotics), especially if severe, bloody, or watery (may be a sign of C. difficile-associated diarrhea, a potentially life-threatening condition)
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain, which may cause:
+ Headache
+ Blurred vision
+ Double vision
+ Loss of vision (may be permanent)
Thyroid cancer (rarely reported with long-term use), which may cause:
+ Lasting hoarseness
+ Neck mass
+ Trouble breathing or swallowing
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and be life-threatening
+ Signs include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects, such as:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness

If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. They can help you manage or alleviate these effects.

Reporting Side Effects

If you have concerns about side effects or want to report any, you can:

Contact your doctor
Call the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have taken any of the following medications: Acitretin, isotretinoin, or a penicillin.
If you are pregnant or think you may be pregnant. Note that this medication is not recommended during pregnancy.
If you are planning to become pregnant or father a child.
* If you are breastfeeding or plan to breastfeed. You may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and laboratory personnel that you are taking this drug.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. When taking this medication, be cautious when exposed to sunlight, as it may cause increased sensitivity to sunburn. If you experience easy sunburning while on this medication, notify your doctor.

In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the discoloration will not fade. Discuss this risk with your doctor. This medication is not approved for use in children under 12 years old, so consult with your doctor to determine the best course of treatment.

Children under 8 years old should not be given this medication. Although rare, tooth discoloration has also been reported in adults, but this condition typically reverses after the medication is discontinued and a dental cleaning is performed. Consult your doctor if you have concerns.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, use an additional form of birth control, such as a condom, while on this medication.

If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may harm the unborn baby.

• Isotretinoin (risk of pseudotumor cerebri)
• Acitretin (risk of pseudotumor cerebri)

• Oral anticoagulants (e.g., Warfarin - enhanced anticoagulant effect)
• Penicillins (tetracyclines may interfere with the bactericidal action of penicillins)
• Ergot alkaloids (theoretical risk of ergotism, though less documented for minocycline)
• Live bacterial vaccines (e.g., Typhoid vaccine - may reduce efficacy)

• Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
• Iron preparations (decreased minocycline absorption)
• Bismuth subsalicylate (decreased minocycline absorption)
• Oral contraceptives (potential for decreased efficacy of oral contraceptives, though evidence is weak)
• Methotrexate (increased methotrexate toxicity)
• Digoxin (increased digoxin levels in some patients)
• Sucralfate (decreased minocycline absorption)

• None commonly cited as minor with significant clinical impact for minocycline ER 45mg.

• Dizziness
• Vertigo
• Lightheadedness
• Nausea
• Vomiting
• Diarrhea
• Photosensitivity (severe sunburn)
• Rash
• Headache (severe, persistent)
• Blurred vision or vision changes
• Joint pain or swelling (drug-induced lupus-like syndrome)
• Sore throat or fever (blood dyscrasias)
• Difficulty swallowing or painful swallowing (esophageal irritation)

Minocycline is classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., tooth discoloration, inhibition of bone growth, candidiasis), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. LactMed classifies it as L3 (moderately safe).

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration and inhibition of bone growth. Use in adolescents (12 years and older) for acne is generally considered safe at appropriate doses.

No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced renal or hepatic function, which could necessitate dose adjustment or closer monitoring for adverse effects. Increased susceptibility to dizziness and lightheadedness may occur.

• Minocycline ER is often preferred over other tetracyclines for acne due to its once-daily dosing and generally better tolerability profile regarding GI upset, though dizziness can be a common side effect.
• Counsel patients extensively on photosensitivity and the importance of sun protection.
• Warn patients about the potential for irreversible skin, nail, and tooth discoloration with prolonged use, especially at higher doses. Blue-gray discoloration of the skin, particularly in sun-exposed areas, can occur.
• Educate patients on the symptoms of pseudotumor cerebri (idiopathic intracranial hypertension) and the need for immediate medical attention if they occur.
• Minocycline can cause a drug-induced lupus-like syndrome, especially with prolonged use. Monitor for symptoms like arthralgia, myalgia, rash, and fever.
• Take with plenty of water to minimize the risk of esophageal irritation and ulceration.

• Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Benzoyl peroxide
• Oral retinoids (e.g., isotretinoin for severe acne)
• Hormonal therapies (e.g., oral contraceptives, spironolactone for female acne)
• Other oral antibiotics (e.g., azithromycin, trimethoprim/sulfamethoxazole - less common for acne)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.