Products

RITOSA

Ritosa is NSAID’S and it is trio combination therapy to combat Moderate to Severe acute inflammatory condition it is panacea especially in toothache condition. It is combination of Diclofenac Potassium which is mainly inhibits COX-1 and partially COX-2 path .it is fast & Potent acting NSAIDS exhibits anti-inflammatory ,analgesic & antipyretic effects. Nimesulide in Ritosa has multifactorial mode of action gives it a unique and broad action on inflammatory processes .it is selective COX-2 inhibitor thus made idle choice as anti-inflammatory, analgesic and antipyretic. Serratiopeptidase in Ritosa is proteolytic enzyme produced by enterobacterium serratia sp. E-15 used in the prevention of pain and swelling (Odema).Moreover it help in digestion of non-living protein thereby improve blood circulation and ensure availability of drugs at site of action.

For Doctors
Formulation

Composition

Ritosa Tablets

Each film coated Tablet contains:

Diclofenac Potassium………………… 50 mg

Nimesulide …………..………...………  100 mg

Serratiopeptidase……………………….. 10 mg

(As enteric coated granules 20000 serratiopeptidase units)

Mechanism of action

Diclofenac Potassium               

The primary mechanism responsible for its anti-inflammatory, antipyretic, and analgesic action is thought to be inhibition of prostaglandin synthesis by inhibition of cyclooxygenase (COX). It also appears to exhibit bacteriostatic activity by inhibiting bacterial DNA synthesis.

Absorption- Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available. plasma levels are observed within 10 minutes of dosing with Diclofenac Potassium immediate-release tablets. Peak plasma levels are achieved approximately 1 hour . Food has no significant effect on the extent of diclofenac absorption.

Distribution-Diclofenac is more than 99% bound to human serum proteins. Serum protein binding is constant over the concentration range (0.15-105 μg/mL) achieved with recommended doses. Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.

Metabolism-Metabolites in human plasma and urine and affected in case on renal dysfunction.

Distribution-Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. The terminal half-life of unchanged diclofenac is approximately 2 hours.

Nimesulide

Nimesulide is a selective COX-2 inhibitor used in variety of inflammatory, pain and fever status.

Absorption- Mean Peak concentration (Cmax) 2.86 to 6.50 mg/L were achieved within 1.22 to 2.75 hours of administration. Food didn’t reduce the absorption.

Distribution- It is rapidly distributed and has apparent volume of distribution ranging between 0.18-0.39 L/kg . it is extensively bounded to plasma protein , the unbound fraction in plasma was 1%. The unbound fraction increased to 2 and 4% in patients with renal or hepatic insufficiency.

Metabolism- It is largely eliminated via metabolic transformation and principal active metabolite is the 4′-hydroxyl derivative (M1).

Excreation- Excretion in the urine and faeces accounted for 50.5 to 62.5% and 17.9 to 36.2% of an orally administered dose, respectively. The total plasma clearance of nimesulide, was 31.02 to 106.16 ml/h/kg, reflecting almost exclusive metabolic clearance. 

 Hepatic insufficiency affected the pharmacokinetics of nimesulide and M1 to a significant extent: the rate of elimination of nimesulide and M1 was remarkably reduced in comparison to the rate of elimination in healthy individuals.

Serratiopeptidase

Absorption-Serratiopeptidase is absorbed through the intestines and transported directly into the bloodstream. But being a peptide there would be a high propensity of this enzyme to undergo enzymatic degradation in the gastrointestinal tract and low membrane permeability due to the hydrophilic nature of peptides and proteins in general. Therefore it is preferably given in enteric coated form to reduce degradation. It was seen that the peak concentration in plasma and lymph at a dose of 100mg/kg were 0.87±0.41 and 43±42ng/ml, respectively, and this peak plasma concentration was achieved 0.25–0.5h after the dose and disappeared by 6h.

Distribution- Distributed to the inflammatory site via blood or lymph. it is quite rapidly transferred to site of inflammation in an enzymatically active form

Metabolism- It takes place through liver

Excretion- It excreted through faces and urine

Indication

Acute Inflammatory Condition

Pre & Post Operative Conditions

Adjuvant to Antibiotic Therapy in URTI & LRTI

Acute Musclo-Skeletal Disorders

Ankylosing Spondolitis

Dental Inflammatory Conditions Like Gingivitis,  Periodontitis , Toothache

Dosages & Administration

Ritosa can be taken one tablet twice daily or thrice daily after meal for 7-15 days.

Adverse Drug Reaction

Ritosa may manifest rare and negligible adverse effects like abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, gastrointestinal ulcers and vomiting.

Drug Interaction

With ACE Inhibitors-Studies suggest that the action of anti hypertensive drug (ACE inhibitors) may be reduced by Diclofenac potassium.

With Aspirin-Proteins binding of Diclofenac potassium will be reduced if it is taken with Aspirin. Concomitant administration of Diclofenac and aspirin is not recommended.

With Warfarin-Use of Warferin and Diclofenac potassium at a time is contraindicated as both the drug act synergistically in GI bleeding. It may lead to serious GI bleeding.

With furosemide – Decreases bioavailability 

Warning & Precaution

Hypersensitivity with Diclofenac,Nimesulide & Serratiopeptidase. 

Active stomach or duodenal ulceration or gastrointestinal bleeding.

pregnancy.

Severe insufficiency of the heart.

Severe liver insufficiency.

Severe renal insufficiency.

Caution in patients with severe, active bleeding such as cerebral hemorrhage.

Patient with past story of experienced stomach discomfort or heartburn after taking NSAIDs must take care before Ritosa therapy starts.

Care must be taken to the patients suffering from asthma, heart disease, liver disease, kidney disease, high blood pressure, a bleeding disorder or other blood disorders, including hepatic porphyria.

Packing

Ritosa 10’s / 72.00

For Patients
What do non-steroidal anti-inflammatory (RITOSA) medications do?

Non-steroidal anti-inflammatory medications (NSAIDs) effectively reduce inflammation and relieve pain. Inflammation is the body's protective response to irritation or injury and is characterized by redness, warmth, swelling, and pain. NSAIDs are used to treat a variety of symptoms such as pain, inflammation, and stiffness caused by rheumatoid arthritis and tendonitis. NSAIDs are also used to treat a variety of other conditions, such as osteoarthritis, muscle aches, backaches, dental pain, pain caused by gout, bursitis, menstrual cramps. They may also be used to reduce fever or relieve minor aches caused by the common cold.

How do NSAIDs (RITOSA) work?

NSAIDs work by blocking the production of certain body chemicals that cause inflammation. NSAIDs are effective in treating pain caused by slow, prolonged tissue damage, such as the pain associated with an arthritic joint. NSAIDs are also effective in treating general or localized pain, such as back pain, menstrual cramps, and headaches.

NSAIDs work like corticosteroids (also called steroids) without many of the side effects associated with steroids. Steroids are man-made drugs that closely resemble cortisone, a naturally-occurring hormone. Like cortisone, NSAIDs are effective in reducing pain and inflammation often associated with joint and muscle diseases and injuries.

How long should I use an NSAID (RITOSA)?

Never use an NSAID (RITOSA) without consulting your health care provider. When taking NSAIDs for long periods of time, it is carefully monitored by your health care provider so he or she can detect the development of harmful side effects and modify your treatment if necessary.

How long does NSAIDs (RITOSA) take to work?

It start working within 15-30 minutes and long lasted for 8-12 hours, suitable for severe acute painful inflammatory condition specially for Dental painful inflammatory condition and others .

For osteoarthritis and rheumatoid arthritis which require long-term treatment we generally recommend NSAIDs that need to be taken only once or twice a day. However, it generally takes longer for these drugs to have a therapeutic effect.

When are NSAIDs (RITOSA) prescribed?

NSAIDs (RITOSA) are often prescribed for Acute Painful inflammatory condition like Dental Inflammatory condition, Pre & Post Operative conditions ,Musculo skeletal disorder like sprains , severe  back pain, ankylosing spondolotis  7-15 days. 

How are NSAIDs prescribed?

NSAIDs  (RITOSA) is  prescribed in different doses, depending on the condition intended to treat. This drugs may need to be taken from once to up to Three times a day. Do NOT increase dose without asking your prescriber first.

How will my health care provider choose a NSAID that is right for me?

The effectiveness and the risks of drugs are considered when your health care provider plans your treatment. Your health care provider will work with you to develop an appropriate treatment program. The drugs that will be prescribed will match the seriousness of your condition. Your health care provider will consider the results of your medical history, physical exam, X-rays, and blood tests to create your treatment plan. Your health care provider will also consider the presence of other medical conditions.

It is important to meet with your health care provider regularly so he or she can detect the development of any harmful side effects and modify your treatment if necessary. Your health care provider may periodically order blood tests or other tests (including a kidney function test) to determine the effectiveness of your treatment and the presence of any harmful side effects.

What are some common side effects of NSAIDs (RITOSA)?

Side effects may occur if you are taking large doses of NSAIDs or if you are taking them for a long period of time. Some side effects are mild and go away, while others are more serious and need medical attention.

Please note: The side effects listed below are the most common side effects. All possible side effects are not included. Always contact your health care provider if you have questions about your particular medication.

The most frequently reported side effects of NSAIDs are gastrointestinal symptoms, such as:

·         Gas

·         Feeling bloated

·         Heartburn

·         Stomach pain

·         Nausea

·         Vomiting

·         Diarrhea and/or constipation

These side effects can generally be relieved by taking the drug with adequate amounts of food. NSAIDs may also be taken with milk or antacids (such as Maalox® or Mylanta®) to prevent gastrointestinal symptoms. If the symptoms continue, the NSAID may need to be stopped. You should contact your health care provider if the symptoms listed above do not stop after a few days of taking the NSAID with food, milk, or antacids.

Some other side effects of NSAIDs include:

·         Dizziness

·         Feeling lightheaded

·         Problems with balance

·         Difficulty concentrating

·         Mild headaches

If these symptoms continue for more than a few days, stop taking the NSAID and contact your health care provider for more instructions.

What side effects should I tell my health care provider about right away?

If you experience any of the following side effects, it is important to call your health care provider right away.

·         Fluid retention (recognized by swelling of the mouth, face, lips or tongue, around the ankles, feet, lower legs, hands and possibly around the eyes)

·         Ringing in the ears

·         Severe rash or hives or red, peeling skin

·         Itching

·         Unexplained bruising and bleeding

·         Unusual weight gain

·         Black stools – bloody or black, tarry stools

·         Bloody or cloudy urine

·         Severe stomach pain

·         Blood or material that looks like coffee grounds in vomit (bleeding may occur without warning symptoms like pain)

·         Blurred vision

·         Wheezing, trouble breathing, or unusual cough

·         Chest pain, rapid heartbeat, palpitations

·         Acute fatigue, flu-like symptoms

·         Jaundice

·         Photosensitivity

Can I take NSAIDs (RITOSA) if I'm being treated for high blood pressure?

Nonsteroidal anti-inflammatory agents can raise blood pressure in some people. Some people with known high blood pressure (hypertension) may have to stop taking NSAIDs, if they notice their blood pressure increases in spite of taking their blood pressure medications and following their diet. If you are taking antihypertension medication consult your health care provider before taking NSAIDs.

Is there anyone who should not take NSAIDs?

People who have the following conditions or circumstances should not use any type of NSAID until they are first evaluated by their health care provider:

·         Children and teenagers with viral infections with or without fever should not receive aspirin or aspirin-containing products due to the risk of Reye’s syndrome

·         Those who have an upcoming surgical procedure, including dental surgery

·         Diabetes that is difficult to control

·         Known kidney disease

·         Known liver disease

·         Known allergies to medications, especially aspirin

·         Active peptic ulcer disease (stomach ulcers or previous history of stomach ulcer bleeding)

·         Bleeding problems (people who have a history of prolonged bleeding time or who bruise easily)

·         People who consume three or more alcoholic beverages per day

·         High blood pressure that is difficult to control

·         Active congestive heart failure

·         Asthma that worsens when taking aspirin

·         Pregnancy in the third trimester

·         Simultaneous use with certain medications such as warfarin (Coumadin®), phenytoin (Dilantin®), cyclosporine (Neoral®, Sandimmune®), probenecid (Benemid®), lithium (Eskalith®, Lithobid®) and drugs used for arthritis, diabetes, high blood pressure, heart disease and vitamins

Can NSAIDs cause allergic reactions?

Very rarely, a non steroidal anti-inflammatory agent can cause a generalized allergic reaction known as anaphylactic shock. If this happens, it generally occurs soon after the person starts taking the NSAID. The symptoms of this reaction include:

·         Swollen eyes, lips, or tongue

·         Difficulty swallowing

·         Shortness of breath

·         Rapid heart rate

·         Chest pain

·         Decrease in sedation

If any of these symptoms occur, call someone drive you to the nearest emergency room immediately.

Before medication is prescribed, tell your health care provider:

·         If you are allergic to any medications, foods or other substances

·         If you are currently taking any other medications (including over-the-counter medications) and/or herbal or dietary supplements.

·         If you are pregnant, planning to become pregnant, or are breast-feeding.

·         If you have problems taking any medications.

·         If you have anemia, kidney or liver disease, stomach or peptic ulcers, heart disease, high blood pressure, bleeding or clotting problems, asthma, or growth in the nose (nasal polyps).

Before you start taking any new medication, ask your health care provider:

·         What is the name of the medication?

·         Why do I need to take it?

·         How often should I take it?

·         What time of day should I take it?

·         Should I take it on an empty stomach or with meals?

·         Where should I store the medication?

·         What should I do if I forget to take a dose?

·         How long should I expect to take the medication?

·         How will I know it is working?

·         What side effects should I expect?

·         Will the medication interfere with driving, working, or other activities?

·         Does the medication interact with any foods, alcohol, or other medications (including over-the-counter medications, herbal and/or dietary supplements)?