Doxycycline Hyclate 50mg DR Tb

Doxycycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the ribosomal acceptor site. This action prevents the addition of amino acids to the growing peptide chain, leading to bacteriostatic effects.

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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Throat irritation
Difficulty swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge
Diarrhea (common with antibiotics), especially if it's severe, watery, or bloody (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)

If you experience any of these symptoms, contact your doctor right away. Additionally, be aware that:

C. diff-associated diarrhea (CDAD) may occur during or after antibiotic treatment, which can lead to a life-threatening bowel condition. If you have stomach pain, cramps, or severe diarrhea, contact your doctor immediately.
Raised pressure in the brain has been reported with this medication, which may cause headaches or vision problems (such as blurred vision, double vision, or loss of vision). If you experience any of these symptoms, seek medical attention right away.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
Decreased appetite

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online 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 symptoms you experienced.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are on long-term treatment with this drug, your doctor may recommend regular blood tests to monitor your condition.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab 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.

You may be more susceptible to sunburn while taking this medication, so take necessary precautions when exposed to the sun. If you experience unusual sunburn or sensitivity, inform your doctor promptly.

There is a risk of severe skin reactions associated with this medication, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that can affect internal organs. These reactions can be life-threatening. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

If you are using birth control pills or other hormone-based contraceptives, note that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as a condom, to prevent pregnancy.

In children under 8 years old, this medication may cause permanent tooth discoloration (yellow-gray brown) or affect bone growth. If taken during pregnancy, it may also cause tooth discoloration in the unborn baby. These changes are irreversible. Other tooth problems have been reported in children taking this medication. Discuss any concerns with your doctor.

Although this medication is not typically recommended for children under 8 years old, there may be exceptions. Consult with your doctor to determine the best course of treatment.

In some cases, adults have also experienced tooth discoloration, which has been reported to reverse after stopping the medication and undergoing dental cleaning. Discuss any concerns with your doctor.

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

• Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption.
• Iron preparations: Decreased doxycycline absorption.
• Bismuth subsalicylate: Decreased doxycycline absorption.
• Oral retinoids (e.g., isotretinoin, acitretin): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
• Penicillins: Tetracyclines may interfere with the bactericidal action of penicillins.

• Oral contraceptives: May reduce efficacy of oral contraceptives (though evidence is weak, advise backup contraception).
• Warfarin: May potentiate anticoagulant effects (monitor INR).
• Barbiturates (e.g., phenobarbital), Carbamazepine, Phenytoin: May decrease doxycycline half-life due to enzyme induction.
• Methotrexate: May increase methotrexate toxicity (rare, but possible).

• Digoxin: May increase digoxin levels (rare).

• Severe headache
• Blurred vision
• Diplopia (double vision)
• Loss of vision (signs of pseudotumor cerebri)
• Severe skin rash or blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Severe abdominal pain
• Persistent nausea or vomiting
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual fatigue (signs of hepatotoxicity)
• New or worsening diarrhea (Clostridioides difficile-associated diarrhea)
• Sunburn-like reaction with minimal sun exposure (photosensitivity)

Contraindicated during the second and third trimesters of pregnancy due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus. Use in the first trimester should be avoided unless the potential benefit outweighs the risk.

Doxycycline is excreted into breast milk. While the amount is generally low and calcium in milk may chelate the drug, leading to minimal infant exposure, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Monitor infant for diarrhea, candidiasis, or tooth discoloration. Short-term use may be acceptable; long-term or repeated use should be avoided.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia. May also cause reversible inhibition of bone growth. Use in children 8 years and older should be carefully weighed against the benefits, especially for severe or life-threatening infections where alternatives are not suitable.

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects such as photosensitivity or gastrointestinal irritation. Monitor renal and hepatic function, though doxycycline is largely non-renally eliminated.

• Doxycycline delayed-release formulations (like Doryx, Oracea) are designed to reduce GI side effects, particularly esophageal irritation, compared to immediate-release forms.
• Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30 minutes to an hour to prevent esophageal ulceration.
• Photosensitivity is a common and significant side effect; counsel patients on sun protection (sunscreen, protective clothing, avoiding prolonged sun exposure).
• Despite being a tetracycline, doxycycline is generally safe for use in patients with renal impairment as it is primarily eliminated via non-renal pathways.
• For acne and rosacea, low-dose doxycycline (e.g., 20 mg BID or 40 mg once daily DR) is used for its anti-inflammatory properties, not primarily its antimicrobial effect, and typically requires a longer course of therapy.
• Advise patients to separate doxycycline administration from antacids, iron, calcium, and dairy products by at least 2-3 hours to ensure adequate absorption.

• Other tetracyclines (e.g., minocycline, tetracycline)
• Macrolides (e.g., azithromycin, erythromycin, clarithromycin) for respiratory or skin infections
• Beta-lactam antibiotics (e.g., penicillins, cephalosporins) for susceptible bacterial infections
• Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible bacterial infections
• Topical or other systemic agents for acne/rosacea (e.g., topical retinoids, benzoyl peroxide, metronidazole, oral isotretinoin)

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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.