Doxycycline 40 mg Capsule, 30-count — NDC 60505-4775-3 (Billing 60505-4775-03)
This is a package of 30 capsules of Doxycycline 40 mg Capsule from Apotex Corp., marketed since Oct 2024 and currently FDA-listed; retail pharmacies pay about $4.67 per capsule (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 060942
- GCN: 27097
- HICL (First Databank): 004014
- AHFS class code: 08:12.24.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Doxycycline is used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. Doxycyline is also used to prevent malaria and to treat acne and rosacea (a skin disease that causes redness, flushing, and pimples on the face) Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by stopping bacteria from growing and spreading. It works to treat acne by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne. It works to treat rosacea b...
Read the full MedlinePlus article ↗- It is an antibiotic for bacterial infections such as rickettsial infections, sexually transmitted infections, respiratory tract infections and eye infections. Some products are als...
- Take it exactly as your prescriber and label say. Swallow capsules with a full glass of water and avoid taking them right before lying down. For one capsule product, take it at lea...
- Diarrhea, nausea, vomiting, stomach upset and loss of appetite are the most common. You may also sunburn much more easily, so cover up and avoid tanning beds. Call me or your docto...
- Call right away for severe or watery diarrhea, a blistering or peeling rash, headache with vision changes, trouble swallowing, or signs of an allergic reaction. Diarrhea can show u...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Doxycycline — tap one for details:
Doxycycline may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.671 | $140.12 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $11.52 | $345.62 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $14.01 | $420.21 / 30 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60505-4775-03 You're viewing this Main listing | 30 CAPSULE in 1 BOTTLE | 2024-10-31 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxycycline 40 mg 11788-0134-30 | AiPing | 30 capsules | $4.671 | AB | Availability likely | — |
| Doxycycline 40 mg 43547-0590-03 | Solco | 30 capsules | $4.671 | AB | Availability likely | — |
| Doxycycline 40 mg 43598-0457-30 | Dr.Reddys | 30 capsules | $4.671 | AB | Availability likely | — |
| Doxycycline 40 mgthis 60505-4775-03 | Apotex | 30 capsules | $4.671 | AB | Availability likely | — |
| Doxycycline 40 mg 62332-0785-30 | Alembic | 30 capsules | $4.671 | AB | Availability likely | — |
| Doxycycline 40 mg 68308-0668-30 | Mayne | 30 capsules | $4.671 | AB | Availability likely | — |
| Doxycycline 40 mg 70748-0308-06 | Lupin | 30 capsules | $4.671 | AB | Availability likely | — |
| Oracea 40 mg 00299-3822-02 | Galderma | 192 capsules | — | AB | Discontinued | — |
| doxycycline 40 mg 33342-0346-07 | Macleods | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 40 mg 46708-0785-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Doxycycline 40 mg 73190-0040-30 | AvKARE | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 5KY68S2577
A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
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UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Doxycycline is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ( 1.1 ) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
( 1.2 ) Doxycycline capsules has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. ( 1.2 )
1.1Indication Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.
1.2Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline capsules should be used only as indicated.
Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Take one doxycycline capsules (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. ( 2.1 ) Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms. ( 2.2 , 5.9 )
2.1General Dosing Information Take one doxycycline capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions ( 6 )].
2.2Important Considerations for Dosing Regimen The dosage of doxycycline capsule differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 40 mg hard gelatin capsule with beige opaque body and beige opaque cap, imprinted “APO D40” in black ink. Filled with mixture of white to off-white and pale yellow, round shape, biconvex tablets. 40 mg capsule. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any other tetracyclines. Doxycycline is contraindicated in persons who have shown hypersensitivity to doxycycline or other tetracyclines. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS The use of doxycycline capsules during tooth development (the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.1 , 5.2 , 8.1 , 8.4 ) Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile . If C. difficile associated diarrhea occurs, discontinue doxycycline capsules ( 5.3 ) If renal impairment exists, doxycycline capsules doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury.
( 5.4 ) Photosensitivity can occur with doxycycline capsules; Patients should minimize or avoid exposure to natural or artificial sunlight. ( 5.5 ) Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue doxycycline capsules immediately. ( 5.6 ) Doxycycline may cause pseudotumor cerebri (benign intracranial hypertension).
Discontinue doxycycline capsules. if symptoms occur. ( 5.8 ) Bacterial resistance to tetracyclines may develop in patients using doxycycline capsules. It should only be used as indicated.
( 5.9 )
5.1Inhibition of Bone Growth During Fetal and Pediatric Development Doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during the second and third trimesters of pregnancy, infancy, and childhood. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours.
This reaction was shown to be reversible when the drug was discontinued. If doxycycline is used during the second or third trimester of pregnancy, advise the patient of the potential risk to the fetus [see Use in Specific Populations ( 8.1 )].
5.2Tooth Discoloration During Fetal and Pediatric Development The use of tetracycline class drugs orally during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses. Enamel hypoplasia has also been reported.
Use of tetracycline drugs is not recommended during tooth development [see Use in Specific Populations ( 8.1 )].
5.3Clostridium difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate management should be instituted as clinically indicated.
5.4Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of t… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Doxycycline Capsules: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received doxycycline capsules or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm: Table 1.
Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline Capsules (n=269) vs. Placebo (n=268) Doxycycline capsules Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Note: Percentages based on total number of study participants in each treatment group.
Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity. Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.
Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [see Dosage and Administration ( 2 )]. Renal toxicity: Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions ( 5.4 )]. Skin: maculopapular and erythematous rashes.
Exfoliative dermatitis. Photosensitivity is discussed above [see Warnings and Precautions ( 5.5 )] . Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.
6.2Postmarketing Adverse Reactions Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of doxycycline capsules. Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.
Skin: fixed drug eruption Psychiatric: depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) Some bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. ( 7.2 ) The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. ( 7.3 )
7.1Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
7.2Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
7.3Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
7.4Antacids and Iron Preparations Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.
7.5Oral Retinoids There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.
7.6Barbiturates and Anti-epileptics Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
7.7Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended ( 8.2 )
8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.1 and 5.2 ) ]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline capsules during the second and third trimester of pregnancy.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses.
Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
8.2Lactation Risk Summary Based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. There is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. Because there are other antibacterial drug options available to treat rosacea in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with doxycycline capsules and for 5 days after the last dose.
8.4Pediatric Use Doxycycline should not be used in infants and children less than 8 years of age [see Warnings and Precautions ( 5.1 )] . Doxycycline has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.
8.5Geriatric Use Clinical studies of doxycycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.1 and 5.2 ) ]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline capsules during the second and third trimester of pregnancy.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses.
Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
🧒 Pediatric Use ▾
8.4Pediatric Use Doxycycline should not be used in infants and children less than 8 years of age [see Warnings and Precautions ( 5.1 )] . Doxycycline has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of doxycycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of doxycycline in the treatment of inflammatory lesions of rosacea is unknown.
12.3Pharmacokinetics Doxycycline capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of doxycycline capsules was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for doxycycline capsules following single oral doses and at steady-state in healthy subjects are presented in Table 2.
Table 2. Pharmacokinetic Parameters [Mean (±SD)] for Doxycycline Capsules N C max * (ng/mL) T max + (hr) AUC 0-oo * (ng•hr/mL) t1/2* (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3 (1 to 4.1) 9227± 3212.8 21.2 ±
7.6Steady-State# 40 mg capsules 31 600 ± 194.2 2 (1 to 4) 7543 ± 2443.9 23.2 ± 6.2 *Mean + Median # Day 7 Absorption: In a single-dose food-effect study involving administration of doxycycline to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if doxycycline is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.
Distribution : Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of doxycycline.
Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric : Doxycycline pharmacokinetics have not been evaluated in pediatric patients [see Warnings and Precautions ( 5.1 )] . Gender: The pharmacokinetics of doxycycline capsules were compared in 16 male and 14 female subjects under fed and fasted conditions.
While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass. Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function.
Hemodialysis does not alter the serum half-life of doxycycline. Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH.
This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric. Drug Interactions: [see Drug Interactions ( 7 )].
12.4Microbiology Doxycycline is a member of the tetracycline-class of drugs. The plasma concentrations of doxycycline achieved with doxycycline capsules during administration [see Clinical Pharmacology ( 12.3 ) and Dosage and Administration ( 2.2 )] are less than the concentration required to treat bacterial diseases. Doxycycline capsules should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease [see Indications and Usage ( 1.2 )].
In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long term effects on bacterial f… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of doxycycline in the treatment of inflammatory lesions of rosacea is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 40 mg hard gelatin capsule with beige opaque body and beige opaque cap, imprinted “APO D40” in black ink. Filled with mixture of white to off-white and pale yellow, round shape, biconvex tablets. Bottle of 30 (NDC 60505-4775-3) Bottle of 500 (NDC 60505-4775-5) Storage: All products are to be stored at controlled room temperatures of 59°F to 86°F (15°C to 30°C) and dispensed in tight, light-resistant containers (USP).
Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Doxycycline capsules 40 mg are hard gelatin capsule shells filled with 33.25 mg immediate release and 6.75 mg delayed release minitablets that together provide a dose of 40 mg of doxycycline. The structural formula of doxycycline, USP is: with a molecular formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.45; 444.43 (anhydrous). The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate (USP).
It is very slightly soluble in water. Doxycycline capsules are supplied in 40 mg strength for oral administration containing doxycycline as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer (1:2), microcrystalline cellulose, talc, and triethyl citrate. FDA approved dissolution test method and specifications differ from USP.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Patients taking doxycycline capsules 40 mg should receive the following information and instructions: Advise pregnant women that doxycycline, like other tetracycline-class drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.1 and 5.2 ) and Use in Specific Populations ( 8.1 )]. Advise women not to breastfeed during treatment with doxycycline and for 5 days after the last dose [see Use in Specific Populations ( 8.2 )].
Advise patients that use of tetracycline class drugs orally during tooth development (infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Advise patients that use of doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during infancy and childhood. Advise patients that pseudomembranous colitis can occur with doxycycline therapy.
If patients develop watery or bloody stools, they should seek medical attention. Advise patients that pseudotumor cerebri can occur with doxycycline therapy. If patients experience headache or blurred vision they should seek medical attention.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including doxycycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline. If patients need to be outdoors while using doxycycline, 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 sunburn. Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including doxycycline. 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. Counsel patients about discoloration of skin, scars, teeth or gums that can arise from doxycycline therapy. Advise patients to take doxycycline capsules exactly as directed.
Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future. APOTEX INC DOXYCYCLINE CAPSULES 40 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Rev. 7
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Doxycycline capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of doxycycline capsules was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for doxycycline capsules following single oral doses and at steady-state in healthy subjects are presented in Table 2.
Table 2. Pharmacokinetic Parameters [Mean (±SD)] for Doxycycline Capsules N C max * (ng/mL) T max + (hr) AUC 0-oo * (ng•hr/mL) t1/2* (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3 (1 to 4.1) 9227± 3212.8 21.2 ±
7.6Steady-State# 40 mg capsules 31 600 ± 194.2 2 (1 to 4) 7543 ± 2443.9 23.2 ± 6.2 *Mean + Median # Day 7 Absorption: In a single-dose food-effect study involving administration of doxycycline to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if doxycycline is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.
Distribution : Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of doxycycline.
Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric : Doxycycline pharmacokinetics have not been evaluated in pediatric patients [see Warnings and Precautions ( 5.1 )] . Gender: The pharmacokinetics of doxycycline capsules were compared in 16 male and 14 female subjects under fed and fasted conditions.
While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass. Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function.
Hemodialysis does not alter the serum half-life of doxycycline. Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH.
This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric. Drug Interactions: [see Drug Interactions ( 7 )].
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of doxycycline in the treatment of only inflammatory lesions (papules and pustules) of rosacea was evaluated in two randomized, placebo-controlled, multi-centered, double-blind, 16-week Phase 3 trials involving 537 subjects (total of 269 subjects on doxycycline from the two trials) with rosacea (10 to 40 papules and pustules and two or fewer nodules). Mean baseline lesion counts were 20 and 21 for doxycycline capsules and placebo subject groups respectively. Pregnant and nursing women, subjects <18 years of age, and subjects with ocular rosacea and/or blepharitis/meibomianitis who require ophthalmologic treatment were excluded from trials.
At Week 16, subjects in the doxycycline capsules group were evaluated using co-primary endpoints of mean reduction in lesion counts and a dichotomized static Investigator’s Global Assessment of Clear or Almost Clear (defined as 1 to 2 small papules or pustules) when compared to the placebo group in both Phase 3 trials. Table 3: Clinical Results of D oxycycline capsules versus Placebo Study 1 Study 2 Doxycycline capsules Placebo Doxycycline capsules Placebo 40 mg N=127 N=124 40 mg N=142 N=144 Mean Change in Lesion Count from Baseline -11.8 -5.9 -9.5 -4.3 No.
(%) of Subjects Clear or Almost Clear in the IGA* 39 (30.7%) 24 (19.4%) 21 (14.8%) 9 (6.3%) *Investigator’s Global Assessment Subjects treated with doxycycline capsules did not demonstrate significant improvement in erythema when compared to those treated with placebo.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use doxycycline capsules [exposure comparison based upon area under the curve (AUC) values].
No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied. Doxycycline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.
Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre and post-implantation losses.
Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of doxycycline capsules when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline capsules on human fertility is unknown.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use doxycycline capsules [exposure comparison based upon area under the curve (AUC) values].
No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied. Doxycycline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.
Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre and post-implantation losses.
Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of doxycycline capsules when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline capsules on human fertility is unknown.
📄 Patient Package Insert ▾
PATIENT INFORMATION Doxycycline (dox’’ i sye’ kleen) capsules Read this Patient Information before you start taking doxycycline capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
What are doxycycline capsules? Doxycycline capsules are a tetracycline class medicine. Doxycycline capsules are a prescription medicine used in adults to treat only pimples or bumps (papules and pustules) caused by a condition called rosacea.
Doxycycline capsules do not lessen redness caused by rosacea. Doxycycline capsules should not be used for the treatment or prevention of infections. It is not known if doxycycline capsules are: effective for use for longer than 16 weeks. safe for use longer than 9 months. safe and effective in children.
Doxycycline capsules should not be used in infants and children less than 8 years of age because it may cause stained teeth in infants and children Who should not take doxycycline capsules? Do not take doxycycline capsules if you are allergic to doxycycline or other medicines in the tetracycline class. Ask your doctor or pharmacist for a list of these medicines if you are not sure.
What should I tell my doctor before taking doxycycline capsules? Before you take doxycycline capsules tell your doctor if you: have kidney problems. have liver problems. have diarrhea or watery stools. have vision problems. have had surgery on your stomach (gastric surgery). have or had a yeast or fungal infection in your mouth or vagina. have any other medical condition. are pregnant or plan to become pregnant. Doxycycline capsules may harm your unborn baby.
Taking doxycycline capsules while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking doxycycline capsules and call your doctor right away if you become pregnant while taking doxycycline capsules. are breastfeeding or plan to breastfeed. Doxycycline can pass into your breast milk and may harm your baby.
Talk to your doctor about the best way to feed your baby if you take doxycycline capsules. You and your doctor should decide if you will take doxycycline capsules or breastfeed. You should not do both.
Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Doxycycline capsules and other medicines can affect each other causing serious side effects. Especially tell your doctor if you take: a blood thinner medicine. a penicillin (antibacterial medicine). proton pump inhibitors or antacids that contain aluminum, calcium, or magnesium. products containing iron or bismuth subsalicylate. a medicine taken by mouth that contains isotretinoin or acitretin. a medicine to treat seizures, such as carbamazepine or phenytoin.
Ask your doctor or pharmacist for a full list of these medicines, if you are not sure. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take doxycycline capsules? Take doxycycline capsules exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your chance of side effects, including the chance that bacteria will become resistant to doxycycline capsules.
Take doxycycline capsules 1 time a day in the morning on an empty stomach. You should take doxycycline capsules at least one hour before or two hours after a meal. Take doxycycline capsules with enough fluid to completely swallow the capsule and to lower your risk of getting irritation or ulcer in your esophagus.
Your esophagus is the tube that connects your mouth to your stomach. If you took too many doxycycline capsules call your doctor right away. Your doctor may do blood tests during treatment with doxycycline capsules to check for side effects.
What should I avoid while taking doxycycline capsules? Avoid sunlight or artificial sun… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Representative sample of labeling (see HOW SUPPLIED section of complete listing): APOTEX CORP. NDC 60505-4775-3 Doxycycline Capsules 40mg 30 counts Rx only