GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Doxycycline for Injection USP 100mg (Doxitaj)
B. Doxycycline for Injection USP 200mg (Doxitaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Doxycycline for Injection USP 100mg
a) Each Vial Contains:
Doxycycline Hyclate (Sterile) USP
Equivalent to Doxycycline ….…….100 mg

b) Ascorbic Acid Injection USP
Each 5ml contains:
Ascorbic acid USP……………….500mg
Water for Injection USP…………. q.s

c) Sterile Water for Injection USP……10ml

2) Doxycycline Hydrochloride USP 200mg
a) Each Vial Contains:
Doxycycline Hyclate (Sterile) USP
Equivalent to Doxycycline ….…….200 mg

b) Ascorbic Acid Injection USP
Each 5ml contains:
Ascorbic acid USP……………….500mg
Water for Injection USP…………. q.s

c) Sterile Water for Injection USP……10ml

THERAPEUTIC INDICATIONS:

Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne

DIRECTION OF USE:

MUST BE FURTHER DILUTED AFTER RECONSTITUTION
Reconstituted solutions must be stored and used as prescribed. They must be used within the time period as described. Protect solution from direct sunlight during infusion.
1. Each 100mg of Doxycycline (i.e. withdraw entire solution from the 100 mg vial) is further diluted with 100 to 1000 mL of the intravenous solutions listed below:
A. 0.9% Sodium Chloride Injection USP
B. 5% Dextrose Injection BP

This will result in desired concentrations of 0.1 to 1 mg/mL concentrations lower than 0.1 mg/mL or higher than 1mg/mL are not recommended.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

Reconstituted solution should be used immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Retain in carton until time of use:
Reconstituted solutions must be stored and used as prescribed.
They must be used within the time period as described.
Protect solution from direct sunlight during infusion.

WARNING: To be sold by retail on the prescribed of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store in cool, dry & dark place. Store at 20°C to 25°C. Protect from light Vial stopper do not contain natural rubber latex.
Keep all medicines out of reach of children.

Dosage: As directed by Physician

Doxycycline for Injection USP Technical Specification:

Product Name:Doxycycline for Injection USP
Brand Name:Doxitaj
Strength:100mg, 200mg
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + 1 Ampule + WFI Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Broad-Spectrum Antibiotic (tetracycline) & Anti-bacterial
Indication: Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria.
Storage:Store in cool, dry & dark place. Store at 20°C to 25°C.  Protect from light

Exporters of Doxycycline for Injection USP in India & International Market:

Ranked as one of the fastest growing companies, Taj Pharma is the trusted name as Doxycycline for Injection USP manufacturer and supplier across the world. Doxycycline for injection USP and other antibacterial medications should only be used to treat or prevent infections that are proven or highly suspected to be caused by bacteria in order to prevent the development of drug-resistant bacteria and maintain the effectiveness of these medications. It is easy to buy Doxycycline for Injection USP online at affordable prices.

Mechanism of Action of Doxycycline for Injection USP

By attaching to the 30S ribosomal subunit, the antibiotic doxycycline prevents bacteria from producing protein. Bacteriostatic activity exists in doxycycline against a variety of Gram-positive and Gram-negative microorganisms.

Side Effects

  • Anorexia
  • Nausea
  • Vomiting
  • Diarrhea
  • Glossitis
  • Dysphagia
  • Enterocolitis
  • Loss of appetite
  • Nausea and vomiting
  • Diarrhea
  • Rash
  • Sensitivity to the sun
  • Hives

Dosage

On the first day of treatment, 200 mg of doxycycline for injection are typically given in one or two infusions. Depending on the infection’s severity; the daily dosage after that ranges from 100 to 200 mg, with 200 mg given in one or two infusions.

300 mg per day for at least 10 days is the recommended dosage for treating both primary and secondary syphilis. Patients with liver problems can use Doxitaj 100mg Injection without any side effects. It is not advised to change the dosage of Doxitaj 100mg Injection. In case you have any health problems related to kidney, let your doctor know about it.

Doxitaj injection could make you feel drowsy and lightheaded, less alert, or have an impact on your vision. If you experience these symptoms, don’t drive. While taking doxycycline, visual problems such as blurred vision could happen.

Precautions

  • In case you have allergy with active or ingredients present in Doxitaj, speak to your doctor without delay.
  • Many people get allergic reactions soon they consume any specific food or take drug. If this is the case, they must share this information to their doctor prior taking this injection.
  • If a patient is allergic to drugs like penicaillin, Acitretin, or any other, let your healthcare provider know about it.
  • It is unknown if drinking alcohol while taking Doxitaj 100mg Injection is safe. Please speak with your healthcare provider.
  • Use of Doxycycline for Injection USP during pregnancy is not advised. Please speak with your physician. Different women may respond differently for the same dose of injection taken. Never compare it with other and consult only the authentic doctor for the same.
  • Use of Doxycycline for Injection USP 100mg Injection while nursing is most likely safe. Still, it is recommended to speak to your doctor before using it.
  • The medicine might cause permanent graying or yellowing of teeth in case of children below an age of 8 years. So, it should be given to them only if the doctor recommends for it.
  • It is observed that if you use this injection along with birth control pills, it may not be that much effective as you might have expected. In such situation, share it with your doctor for alternatives of pills for the same.

GENERIC NAME OF MEDICINAL PRODUCT:

  1. Doxycycline for Injection USP 100mg (Doxitaj)
  2. Doxycycline for Injection USP 200mg (Doxitaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Doxycycline for Injection USP 100mg
a) Each Vial Contains:
Doxycycline Hyclate (Sterile) USP
Equivalent to Doxycycline ….…….100 mg

b) Ascorbic Acid Injection USP
Each 5ml contains:
Ascorbic acid USP……………….500mg
Water for Injection USP…………. q.s

c) Sterile Water for Injection USP……10ml

2) Doxycycline Hydrochloride USP 200mg
a) Each Vial Contains:
Doxycycline Hyclate (Sterile) USP
Equivalent to Doxycycline ….…….200 mg

b) Ascorbic Acid Injection USP
Each 5ml contains:
Ascorbic acid USP……………….500mg
Water for Injection USP…………. q.s

c) Sterile Water for Injection USP……10ml

THERAPEUTIC INDICATIONS:

Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne

DIRECTION OF USE:

MUST BE FURTHER DILUTED AFTER RECONSTITUTION

Reconstituted solutions must be stored and used as prescribed. They must be used within the time period as described. Protect solution from direct sunlight during infusion.

  1. Each 100mg of Doxycycline (i.e. withdraw entire solution from the 100 mg vial) is further diluted with 100 to 1000 mL of the intravenous solutions listed below:
  2. 9% Sodium Chloride Injection USP
  3. 5% Dextrose Injection BP

This will result in desired concentrations of 0.1 to 1 mg/mL concentrations lower than 0.1 mg/mL or higher than 1mg/mL are not recommended.

CAUTION & Warning:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

Reconstituted solution should be used immediately after preparation.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Retain in carton until time of use:
Reconstituted solutions must be stored and used as prescribed.
They must be used within the time period as described.
Protect solution from direct sunlight during infusion.

Warning: To be sold by retail on the prescribed of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Store in cool, dry & dark place. Store at 20°C to 25°C.  Protect from light

Vial stopper do not contain natural rubber latex.

Keep all medicines out of reach of children.

Dosage: As directed by Physician

Doxycycline for Injection USP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Free Sale Certificate (FSC)
  • Stability Data (Accelerated stability / Long term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Method of Analysis (MOA)

Doxycycline for Injection USP Export Market

As a reputable manufacturer and supplier of Doxycycline for Injection USP, we carefully formulate the intravenous injection. The medication is exported to numerous countries throughout the world, including:

Russia and CIS Countries: Belarus, Kazakhstan, Kyrgyzstan, Armenia, Turkmenistan, Uzbekistan, Ukraine, Moldova, Tajikistan, Russia, Georgia, Azerbaijan

African Countries: Tanzania, Angola, Benin, Sudan, Liberia, Nigeria, Zambia

Southeast Asia: Thailand, Laos, Indonesia, Malaysia, Darussalam, Vietnam, Singapore, Brunei, Myanmar, Philippines

GCC/ Middle East Countries: Bahrain, Iraq, Lebanon, Jordan, Oman, Saudi Arabia, UAE, Yemen

Other Asian Countries: Mauritius, Bhutan, Sri Lanka, Myanmar, Cambodia, Malaysia, Nepal