Doxycycline Monohyd 25mg/5ml Susp

Manufacturer LUPIN Active Ingredient Doxycycline Suspension(doks i SYE kleen) Pronunciation doks i SYE kleen
It is used to treat pimples (acne).It is used to treat or prevent bacterial infections.It is used to prevent malaria.It is used to treat swelling of the tissue around the teeth (periodontitis). It is used with scaling and root planing.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Tetracycline Antibiotic
🤰
Pregnancy Category
Category D
✅
FDA Approved
Jun 1967
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Doxycycline is an antibiotic used to treat many different types of bacterial infections, including skin infections, respiratory infections, urinary tract infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria. It can also be used to prevent malaria and treat severe acne.
📋

How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided and follow the instructions carefully.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Some medications should be taken with food or on an empty stomach. Check with your pharmacist to determine the best way to take your medication.
It's best to avoid taking your medication at the same time as milk, dairy products, or other calcium-containing foods, as this may reduce its effectiveness. If you have questions, consult your doctor or pharmacist.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Important Interactions to Avoid

Do not take the following medications or supplements within 2 hours of taking your prescribed medication:
Bismuth (Pepto-Bismol)
Calcium
Iron
Magnesium
Zinc
Multivitamins with minerals
Colestipol
Cholestyramine
Didanosine
Antacids

Measuring and Administering Your Medication

Measure liquid doses carefully using the measuring device provided with your medication. If one is not provided, ask your pharmacist for a suitable device.
Shake the medication well before use.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Do not take your medication if it is past its expiration date or has not been stored properly.

What to Do If You Miss a Dose

Take a missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
💡

Lifestyle & Tips

  • Take with a full glass of water to prevent esophageal irritation.
  • Remain upright for at least 30 minutes (preferably 1 hour) after taking the dose.
  • Avoid taking antacids, iron supplements, calcium supplements, or dairy products within 2-3 hours before or after taking doxycycline, as they can reduce its absorption.
  • Avoid prolonged exposure to sunlight or tanning beds, as doxycycline can make your skin more sensitive to the sun (photosensitivity). Use sunscreen and wear protective clothing.
  • Complete the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Do not give this medication to children under 8 years old unless specifically instructed by a doctor for severe, life-threatening infections, due to the risk of permanent tooth discoloration.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Varies by indication. Common: 100 mg orally every 12-24 hours for infections. For specific uses like malaria prophylaxis, 100 mg once daily.
Dose Range: 20 - 200 mg

Condition-Specific Dosing:

General Infections (moderate to severe): 100 mg orally every 12 hours on day 1, then 100 mg once daily or 50 mg every 12 hours.
Acne Vulgaris (anti-inflammatory dose): 20 mg orally twice daily or 40 mg once daily (modified-release).
Malaria Prophylaxis: 100 mg orally once daily, starting 1-2 days before travel, continuing for 4 weeks after return.
Lyme Disease: 100 mg orally twice daily for 10-21 days.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years due to tooth discoloration and bone effects, unless benefits outweigh risks in severe/life-threatening infections like anthrax or Rocky Mountain spotted fever).
Infant: Not established (contraindicated in children < 8 years).
Child: For children 8 years and older (and weighing less than 45 kg): 4.4 mg/kg/day orally in 1-2 divided doses. Max 100 mg/dose. For children weighing 45 kg or more: Adult dose.
Adolescent: Adult dose (typically 100 mg orally every 12-24 hours).
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed (doxycycline is primarily eliminated via non-renal pathways).
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for signs of hepatotoxicity.
Severe: Use with caution; monitor for signs of hepatotoxicity. Consider dose reduction or alternative if possible.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Doxycycline is a broad-spectrum 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 1.5-4 hours
FoodEffect: Absorption is not significantly affected by food or milk, unlike other tetracyclines. However, absorption can be impaired by divalent and trivalent cations (e.g., aluminum, calcium, magnesium, iron, zinc).

Distribution:

Vd: 0.7-1.2 L/kg
ProteinBinding: 80-95%
CnssPenetration: Limited (poor penetration into CSF, but increases with meningeal inflammation)

Elimination:

HalfLife: 16-22 hours (can be up to 24 hours)
Clearance: Not readily available, but primarily non-renal excretion.
ExcretionRoute: Mainly via feces (biliary excretion and subsequent enterohepatic recirculation followed by fecal excretion) and urine (renal excretion).
Unchanged: Approximately 40% excreted unchanged in urine, 20-40% in feces.
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Within 2-4 hours (peak plasma concentration)
DurationOfAction: 24 hours (allows for once-daily dosing for many indications)

Safety & Warnings

âš ī¸

Side 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 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Chest pain or pressure
Fast heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Throat irritation
Trouble swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge

Important Antibiotic-Related Side Effect:

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Rare but Serious Side Effect:

Raised pressure in the brain has been reported with this medication. In most cases, this condition resolves after stopping the medication. However, in some instances, vision loss may occur and may be permanent. If you experience a headache or vision problems, such as blurred vision, double vision, or loss of vision, seek medical attention immediately.

Other Possible Side Effects:

Most people do not experience significant side effects or only have mild side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe diarrhea (watery or bloody)
  • New or worsening abdominal cramps
  • Fever
  • Severe skin rash, blistering, or peeling skin
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Severe headache, blurred vision, or double vision (signs of increased pressure in the brain)
  • Swelling of the face, lips, tongue, or throat (allergic reaction)
  • Difficulty breathing
📋

Before Using This Medicine

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 other 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.
âš ī¸

Precautions & Cautions

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 contraception, 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 tooth development. Additionally, bone growth may be impacted. If you have concerns, discuss them with your doctor. It is generally recommended to avoid using this medication in children under 8 years old, unless deemed necessary by a healthcare professional.

Tooth discoloration has also been reported in adults, but this condition may be reversible after stopping the medication and undergoing dental cleaning. Consult your doctor if you have any questions or concerns.

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

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Liver damage (rare)
  • Kidney damage (rare)

What to Do:

In case of suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is generally supportive, including gastric lavage if recent ingestion, and symptomatic management.

Drug Interactions

🔴

Major Interactions

  • 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.
  • Warfarin: May potentiate anticoagulant effects (monitor INR).
🟡

Moderate Interactions

  • Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life.
  • Carbamazepine: Decreased doxycycline half-life.
  • Phenytoin: Decreased doxycycline half-life.
  • Oral contraceptives: May decrease efficacy of oral contraceptives (advise backup method).
  • Methotrexate: May increase methotrexate toxicity (tetracyclines can reduce renal clearance of methotrexate).
  • Ergot alkaloids: Possible increased risk of ergotism.
đŸŸĸ

Minor Interactions

  • Dairy products: While less significant than with other tetracyclines, large amounts may slightly reduce absorption if taken concurrently.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Liver function tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as doxycycline is metabolized in the liver.

Timing: Prior to initiation in patients with hepatic impairment or prolonged therapy.

Renal function tests (RFTs)

Rationale: To assess baseline renal function, though dose adjustment is generally not needed for renal impairment.

Timing: Prior to initiation in patients with renal impairment.

📊

Routine Monitoring

Signs of superinfection (e.g., C. difficile-associated diarrhea, candidiasis)

Frequency: Throughout therapy and for several weeks post-therapy.

Target: N/A

Action Threshold: If symptoms occur, discontinue doxycycline and initiate appropriate therapy.

INR (International Normalized Ratio)

Frequency: More frequently (e.g., weekly) if co-administered with warfarin.

Target: Therapeutic range for patient's indication.

Action Threshold: Adjust warfarin dose as needed to maintain target INR.

Signs of photosensitivity

Frequency: Daily during therapy.

Target: N/A

Action Threshold: Advise patient to avoid direct sunlight/UV light; discontinue if severe reaction occurs.

Signs of benign intracranial hypertension (pseudotumor cerebri)

Frequency: Periodically, especially if patient reports headache, blurred vision, or diplopia.

Target: N/A

Action Threshold: Discontinue doxycycline if symptoms occur.

đŸ‘ī¸

Symptom Monitoring

  • Diarrhea (especially severe or persistent)
  • Abdominal pain
  • Nausea/vomiting
  • Esophageal irritation/dysphagia (less common with suspension)
  • Skin rash/hives
  • Sunburn-like reaction (photosensitivity)
  • Headache
  • Blurred vision or double vision (signs of intracranial hypertension)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness

Special Patient Groups

🤰

Pregnancy

Contraindicated during pregnancy, especially during the second and third trimesters, due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus. Use only if the potential benefit justifies the potential risk to the fetus in severe or life-threatening conditions where safer alternatives are not available.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and limb abnormalities, though less established than dental effects. Generally avoided.
Second Trimester: High risk of permanent tooth discoloration and inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration and inhibition of bone growth.
🤱

Lactation

Doxycycline is excreted into breast milk. While the amount is generally low and calcium in milk may chelate the drug, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution. However, it is generally recommended to avoid or use with caution, or consider an alternative, especially for long-term use. Monitor infant for diarrhea, candidiasis, and tooth discoloration.

Infant Risk: L3 - Moderate risk. Potential for tooth discoloration and bone effects, though absorption by infant may be limited due to calcium in milk.
đŸ‘ļ

Pediatric Use

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth. In severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever) where the benefits outweigh the risks, it may be used under strict medical supervision.

👴

Geriatric Use

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

Clinical Information

💎

Clinical Pearls

  • Doxycycline is unique among tetracyclines for its relatively good absorption even with food/dairy, though it's still best to avoid co-administration with antacids/iron.
  • Always advise patients to take with plenty of water and remain upright to prevent esophageal irritation and ulceration.
  • The 25mg/5ml suspension is particularly useful for pediatric dosing (in children â‰Ĩ8 years) or for lower adult doses where precise titration is needed.
  • It has anti-inflammatory properties at sub-antimicrobial doses (e.g., 20 mg BID or 40 mg once daily modified-release) used for acne and rosacea.
  • Photosensitivity is a common side effect; emphasize sun protection.
  • Despite its broad spectrum, it is not effective against all bacteria and should be used judiciously to prevent resistance.
🔄

Alternative Therapies

  • Azithromycin (for some respiratory/skin infections, STIs)
  • Amoxicillin (for some respiratory/skin infections)
  • Ciprofloxacin (for some UTIs, respiratory infections)
  • Clindamycin (for some skin/soft tissue infections)
  • Minocycline (another tetracycline, often used for acne)
  • Tigecycline (glycylcycline, for complicated infections)
💰

Cost & Coverage

Average Cost: Not available per 5ml
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 overdose, including the medication taken, the amount, and the time it occurred.