Promethazine Hydrochloride Tablets USP 25mg Technical Specification:]

Product Name:Promethazine Hydrochloride Tablets USP 25mg
Brand Name:Generic
Strength:(12.5mg), (25mg), (50mg)
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiallergic, Antihistamine
Indication: Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.
Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Promethazine Hydrochloride Tablets USP 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Promethazine Hydrochloride Tablets USP 25mg
    Each Film-coated tablet contains:
    Promethazine Hydrochloride USP
    Equivalent to Promethazine………………..……………25mg
    Excipients…………………………………………………………..q.s
    Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharma is your trusted source for Promethazine Hydrochloride Tablets. With a legacy of pharmaceutical excellence and a commitment to patient well-being, we deliver quality you can rely on. Choose Taj Pharma for your healthcare needs.

  • Pharmaceutical Expertise: Taj Pharma boasts a long-standing legacy of pharmaceutical expertise, setting industry standards for quality and innovation. Our Promethazine Hydrochloride Tablets reflect our dedication to delivering reliable healthcare solutions.
  • Patient-Centered Care: At Taj Pharma, patient well-being is at the core of our mission. Our Promethazine Hydrochloride Tablets are designed to provide effective relief while prioritizing safety and comfort, making us your preferred healthcare partner.
  • Quality Assurance: We uphold the highest standards of quality control, adhering to rigorous international pharmaceutical guidelines. Each Promethazine Hydrochloride Tablet undergoes meticulous testing to ensure safety, efficacy, and consistency in treatment.
  • Global Trust: Taj Pharma is a globally recognized name, trusted by healthcare professionals and patients worldwide. When you choose Taj Pharma, you choose a symbol of excellence in pharmaceuticals.

Opt for Taj Pharma for your Promethazine Hydrochloride Tablets and experience the difference in quality, effectiveness, and patient-centered care. Trust us for your healthcare needs.

What is Promethazine Hydrochloride Tablets and its use?

Promethazine Hydrochloride Tablets are a medication that contains the active ingredient promethazine hydrochloride. Promethazine is a versatile drug with various medical uses, primarily in the management of different conditions related to allergies, nausea, vomiting, and motion sickness. Here’s an overview of its uses:

Uses of Promethazine Hydrochloride Tablets:

  • Allergic Reactions: Promethazine is often prescribed to alleviate allergic reactions, such as itching, swelling, and hives. It can help manage symptoms related to various allergies, including those caused by insect bites and stings.
  • Nausea and Vomiting: Promethazine is effective in reducing nausea and vomiting associated with various conditions, including motion sickness, chemotherapy, and post-operative recovery.
  • Sedation and Sleep Aid: Due to its sedative properties, Promethazine is sometimes used as a sleep aid in individuals experiencing insomnia or difficulty falling asleep.
  • Cough Suppression: Promethazine can be used to suppress coughing in certain cases when non-opioid cough medications are needed.
  • Preoperative Medication: It is sometimes administered before surgery to reduce anxiety and produce sedation prior to anesthesia induction.
  • Motion Sickness: Promethazine is effective in preventing and treating motion sickness, particularly in situations where travel or motion can trigger nausea and vomiting.
  • Migraine Management: In some cases, Promethazine may be used to alleviate the symptoms of migraines, particularly nausea and vomiting associated with migraines.

The use of Promethazine Hydrochloride Tablets should be guided by a healthcare provider. The specific indication, dosage, and duration of treatment will depend on the patient’s condition and medical history. This medication should be taken as prescribed, and any questions or concerns about its use should be discussed with a healthcare professional. Additionally, it may cause drowsiness, so individuals taking Promethazine should exercise caution when operating machinery or engaging in activities requiring mental alertness.

How does Promethazine Hydrochloride Tablets Work?

Promethazine Hydrochloride Tablets work through several mechanisms in the body, leading to their therapeutic effects. Promethazine is classified as a first-generation antihistamine with additional properties that make it useful for various medical purposes. Here’s how Promethazine works:

  • Histamine Blockade: Promethazine is primarily an antihistamine, which means it blocks the action of histamine, a naturally occurring substance in the body. Histamine plays a key role in allergic reactions and is responsible for symptoms like itching, sneezing, runny nose, and swelling. By blocking histamine receptors, Promethazine reduces or prevents these allergic symptoms.
  • Anti-Nausea and Anti-Vomiting: Promethazine has antiemetic properties, meaning it can effectively reduce nausea and vomiting. It works by affecting the vomiting center in the brain, making it less sensitive to stimuli that trigger nausea and vomiting. This action is particularly useful in managing nausea and vomiting caused by various factors, including motion sickness, chemotherapy, surgery, and certain medical conditions.
  • Sedation: Promethazine has sedative effects, making it useful for inducing sleep or reducing anxiety and restlessness. It acts on the central nervous system, depressing certain brain functions and producing a calming effect. This sedation can be helpful in managing insomnia or providing preoperative relaxation.
  • Motion Sickness: Promethazine’s antiemetic and sedative properties make it effective in preventing and treating motion sickness. It reduces the sensitivity of the inner ear’s motion-sensing mechanism, helping to minimize symptoms like dizziness, nausea, and vomiting during travel.
  • Cough Suppression: Promethazine can suppress coughing by acting on the brain’s cough center. It is used in specific cases when non-opioid cough medications are needed.
  • Migraine Relief: Promethazine can provide relief from migraines, particularly by addressing associated symptoms like nausea and vomiting. It helps ease these symptoms and contributes to overall migraine management.

Promethazine hydrochloride is a medication commonly prescribed for various medical conditions. It belongs to a class of drugs known as antihistamines, and it has several benefits as well as potential side effects. It’s important to note that you should always follow your healthcare provider’s instructions and discuss any concerns or questions with them before taking any medication. Here are some benefits and potential side effects of promethazine hydrochloride tablets:

Benefits:

  • Allergy Relief: Promethazine is often used to alleviate allergy symptoms, such as sneezing, runny nose, itching, and watery eyes. It works by blocking the action of histamine, a chemical released during allergic reactions.
  • Nausea and Vomiting: Promethazine can help control nausea and vomiting, making it useful for conditions like motion sickness, chemotherapy-induced nausea and vomiting, and post-operative nausea.
  • Sedation: One of the side effects of promethazine is drowsiness, which can be an advantage when it’s used to help people sleep or manage anxiety and restlessness.
  • Cough Suppression: In some cases, promethazine may be prescribed as a cough suppressant.
  • Preoperative Medication: It is sometimes used as a preoperative medication to help relax patients before surgery.

Side Effects:

  • Drowsiness: Promethazine is known for causing drowsiness, which can impair your ability to perform tasks that require mental alertness, such as driving or operating heavy machinery.
  • Dry Mouth: It can lead to a dry mouth, which can be uncomfortable.
  • Blurred Vision: Promethazine can cause blurred vision, making it difficult to see clearly.
  • Dizziness: Some people may experience dizziness or lightheadedness when taking promethazine.
  • Constipation: It can lead to constipation due to its effects on the digestive system.
  • Difficulty Urinating: Some individuals may experience difficulty urinating while taking promethazine.
  • Nausea and Vomiting (Rare): Paradoxically, promethazine can cause nausea and vomiting in some individuals, although it’s primarily used to treat these symptoms.
  • Extrapyramidal Symptoms (Rare): These are movement disorders that can include tremors, muscle stiffness, and restlessness. They are more common at higher doses or with long-term use.
  • Serious Allergic Reactions (Rare): Although rare, some individuals may experience serious allergic reactions to promethazine, characterized by hives, difficulty breathing, and swelling of the face, lips, tongue, or throat.
  • Low Blood Pressure (Hypotension): In some cases, promethazine can cause a drop in blood pressure, especially when standing up from a sitting or lying position.

Frequently asked questions (FAQs) about Promethazine Hydrochloride Tablets:

  1. What is Promethazine Hydrochloride?

Promethazine hydrochloride is a medication that belongs to the class of drugs known as antihistamines. It is commonly used to treat allergies, nausea, vomiting, and motion sickness.

  1. What conditions can Promethazine Hydrochloride Tablets treat?

Promethazine can be prescribed to treat a variety of conditions, including allergic reactions, motion sickness, nausea and vomiting (including those induced by chemotherapy), and as a sedative.

  1. How does Promethazine work?

Promethazine works by blocking the action of histamine, a chemical produced by the body during allergic reactions. By doing so, it helps relieve symptoms such as itching, sneezing, runny nose, and watery eyes.

  1. Can I use Promethazine for cough and cold symptoms?

Promethazine may be used as a cough suppressant in some cases, but it is not typically recommended for treating common cold symptoms. There are other over the counter medications specifically designed for cold relief.

  1. What are the common side effects of Promethazine Hydrochloride Tablets?

Common side effects include drowsiness, dry mouth, blurred vision, dizziness, constipation, and difficulty urinating. These side effects can vary in severity from person to person.

  1. Is Promethazine safe for children?

Promethazine is not recommended for use in children under the age of 2, and it should be used with caution in older children. It’s essential to follow the dosing instructions provided by a healthcare professional.

  1. Can I take Promethazine while pregnant or breastfeeding?

It’s important to consult with a healthcare provider before taking Promethazine if you are pregnant or breastfeeding. The risks and benefits should be carefully considered, and alternative treatments may be explored.

  1. Can I drink alcohol while taking Promethazine?

It is generally not recommended to consume alcohol while taking Promethazine, as it can increase the risk of drowsiness and other side effects.

  1. Can I drive or operate heavy machinery while taking Promethazine?

Promethazine can cause drowsiness and impair your ability to concentrate. It’s important to avoid activities that require mental alertness, such as driving or operating heavy machinery, until you know how the medication affects you.

  1. Can I take Promethazine with other medications?

Promethazine can interact with other medications, including certain antidepressants and pain relievers. It’s essential to inform your healthcare provider about all the medications you are taking to avoid potential interactions.

  1. How should I store Promethazine Hydrochloride Tablets?

Store Promethazine tablets at room temperature away from moisture and light. Follow the specific storage instructions provided on the medication’s packaging.

  1. What should I do if I miss a dose of Promethazine?

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

As Promethazine Hydrochloride Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Promethazine Hydrochloride Tablets product in the Following Countries-

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

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

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

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

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

Promethazine Hydrochloride Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Promethazine Hydrochloride Tablets, Taj Pharmaceuticals Limited to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Promethazine Hydrochloride tablets USP 12.5mg
B. Promethazine Hydrochloride tablets USP 25mg
C. Promethazine Hydrochloride tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Promethazine Hydrochloride tablets USP 12.5mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………12.5mg
Excipients…………………………………………………..……..q.s
Colour: Sunset yellow FCF

B. Promethazine Hydrochloride tablets USP 25mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………25mg
Excipients…………………………………………………………..q.s
Colour: Sunset yellow


C. Promethazine Hydrochloride tablets USP 50mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………50mg
Excipients…………………………………………………………..q.s
Colour: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.