|
|||
|
DRUGS & SUPPLEMENTS
|
Cultivate
What do you feel about the cost of the medicine? Is it expensive? |
Cultivate uses
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
1 INDICATIONS AND USAGE
Cultivate Nasal Spray is a corticosteroid indicated for treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years.
1.1 Treatment of Allergic Rhinitis
Cultivate® (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
2 DOSAGE AND ADMINISTRATION
Administer Cultivate Nasal Spray by the intranasal route only. Prime Cultivate Nasal Spray before using for the first time by shaking the contents well and releasing 6 sprays into the air away from the face. When Cultivate Nasal Spray has not been used for more than 30 days or if the cap has been left off the bottle for 5 days or longer, prime the pump again until a fine mist appears. Shake Cultivate Nasal Spray well before each use.
Titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects.
For intranasal use only. Usual starting dosages:
- Adults and adolescents ≥12 years: 110 mcg once daily. (2.1)
- Children 2-11 years: 55 mcg (1 spray per nostril) once daily. (2.2)
- Priming information: Prime Cultivate Nasal Spray before using for the first time, when not used for more than 30 days, or if the cap has been left off the bottle for 5 days or longer. (2)
2.1 Adults and Adolescents Aged 12 Years and Older
The recommended starting dosage is 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms.
2.2 Children Aged 2 to 11 Years
The recommended starting dosage in children is 55 mcg once daily administered as 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, dosage reduction to 55 mcg once daily is recommended.
3 DOSAGE FORMS AND STRENGTHS
Cultivate Nasal Spray is a nasal spray suspension. Each spray (50 microliters) delivers 27.5 mcg of Cultivate furoate.
Nasal spray: 27.5 mcg of Cultivate furoate in each 50-microliter spray. (3)
Supplied in 10-g bottle containing 120 sprays. (16)
4 CONTRAINDICATIONS
Cultivate Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients .
Hypersensitivity to ingredients. (4)
5 WARNINGS AND PRECAUTIONS
- Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
- Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. (5.2)
- Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of Cultivate Nasal Spray. (5.3)
- Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. (5.4)
- Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Cultivate Nasal Spray slowly. (5.5)
- Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving Cultivate Nasal Spray. (5.7, 8.4)
5.1 Local Nasal Effects
Epistaxis and Nasal Ulceration
In clinical trials of 2 to 52 weeks’ duration, epistaxis and nasal ulcerations were observed more frequently and some epistaxis events were more severe in patients treated with Cultivate Nasal Spray than those who received placebo .
Candida Infection
Evidence of localized infections of the nose with Candida albicans was seen on nasal exams in 7 of 2,745 patients treated with Cultivate Nasal Spray during clinical trials and was reported as an adverse event in 3 patients. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of Cultivate Nasal Spray. Therefore, patients using Cultivate Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Nasal Septal Perforation
Postmarketing cases of nasal septal perforation have been reported in patients following the intranasal application of Cultivate Nasal Spray .
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use Cultivate Nasal Spray until healing has occurred.
5.2 Glaucoma and Cataracts
Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Glaucoma and cataract formation was evaluated with intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month trial in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week trial in 558 children aged 2 to 11 years. The patients had perennial allergic rhinitis and were treated with either Cultivate Nasal Spray (110 mcg once daily in adult and adolescent patients and 55 or 110 mcg once daily in pediatric patients) or placebo. Intraocular pressure remained within the normal range (less than 21 mmHg) in greater than or equal to 98% of the patients in any treatment group in both trials. However, in the 12-month trial in adolescents and adults, 12 patients, all treated with Cultivate Nasal Spray 110 mcg once daily, had intraocular pressure measurements that increased above normal levels (greater than or equal to 21 mmHg). In the same trial, 7 patients (6 treated with Cultivate Nasal Spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the trial that were not present at baseline.
5.3 Hypersensitivity Reactions, Including Anaphylaxis
Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of Cultivate Nasal Spray. Discontinue Cultivate Nasal Spray if such reactions occur .
5.4 Immunosuppression
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox or measles develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.
5.5 Hypothalamic-Pituitary-Adrenal Axis Effects
Hypercorticism and Adrenal Suppression
When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of Cultivate Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.
5.6 Use of Cytochrome P450 3A4 Inhibitors
Coadministration with ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to Cultivate furoate. Use caution with the coadministration of Cultivate Nasal Spray and other potent cytochrome P450 3A4 inhibitors, such as ketoconazole .
5.7 Effect on Growth
Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving Cultivate Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including Cultivate Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms .
6 ADVERSE REACTIONS
Systemic and local corticosteroid use may result in the following:
- Epistaxis, ulcerations, Candida albicans infection, impaired wound healing, and nasal septal perforation
- Cataracts and glaucoma
- Immunosuppression
- Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction
The most common adverse reactions (>1% incidence) included headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, and cough. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience
The safety data described below reflect exposure to Cultivate Nasal Spray in 1,563 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 to 12 weeks’ duration. The data from adults and adolescents are based upon 6 clinical trials in which 768 patients with seasonal or perennial allergic rhinitis (473 females and 295 males aged 12 years and older) were treated with Cultivate Nasal Spray 110 mcg once daily for 2 to 6 weeks. The racial distribution of adult and adolescent patients receiving Cultivate Nasal Spray was 82% white, 5% black, and 13% other. The data from pediatric patients are based upon 3 clinical trials in which 795 children with seasonal or perennial rhinitis (352 females and 443 males aged 2 to 11 years) were treated with Cultivate Nasal Spray 55 or 110 mcg once daily for 2 to 12 weeks. The racial distribution of pediatric patients receiving Cultivate Nasal Spray was 75% white, 11% black, and 14% other.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Adolescents Aged 12 Years and Older
Overall adverse reactions were reported with approximately the same frequency by patients treated with Cultivate Nasal Spray and those receiving placebo. Less than 3% of patients in clinical trials discontinued treatment because of adverse reactions. The rate of withdrawal among patients receiving Cultivate Nasal Spray was similar to or lower than the rate among patients receiving placebo.
Table 1 displays the common adverse reactions (greater than 1% in any patient group receiving Cultivate Nasal Spray) that occurred more frequently in patients aged 12 years and older treated with Cultivate Nasal Spray compared with placebo-treated patients.
| Adverse Event | Adult and Adolescent Patients Aged 12 Years and Older | |
| Vehicle Placebo (n = 774) | Cultivate Nasal Spray 110 mcg Once Daily (n = 768) | |
| Headache | 54 (7%) | 72 (9%) |
| Epistaxis | 32 (4%) | 45 (6%) |
| Pharyngolaryngeal pain | 8 (1%) | 15 (2%) |
| Nasal ulceration | 3 (<1%) | 11 (1%) |
| Back pain | 7 (<1%) | 9 (1%) |
There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger subjects.
Pediatric Patients Aged 2 to 11 Years
In the 3 clinical trials in pediatric patients aged 2 to younger than 12 years, overall adverse reactions were reported with approximately the same frequency by patients treated with Cultivate Nasal Spray and those receiving placebo. Table 2 displays the common adverse reactions (greater than 3% in any patient group receiving Cultivate Nasal Spray) that occurred more frequently in patients aged 2 to 11 years treated with Cultivate Nasal Spray compared with placebo-treated patients.
| Adverse Event | Pediatric Patients Aged 2 to Younger than 12 Years | ||
| Vehicle Placebo (n = 429) | Cultivate Nasal Spray 55 mcg Once Daily (n = 369) | Cultivate Nasal Spray 110 mcg Once Daily (n = 426) | |
| Headache | 31 (7%) | 28 (8%) | 33 (8%) |
| Nasopharyngitis | 21 (5%) | 20 (5%) | 21 (5%) |
| Epistaxis | 19 (4%) | 17 (5%) | 17 (4%) |
| Pyrexia | 7 (2%) | 17 (5%) | 19 (4%) |
| Pharyngolaryngeal pain | 14 (3%) | 16 (4%) | 12 (3%) |
| Cough | 12 (3%) | 12 (3%) | 16 (4%) |
There were no differences in the incidence of adverse reactions based on gender or race. Pyrexia occurred more frequently in children aged 2 to younger than 6 years compared with children aged 6 to younger than 12 years.
Long-term (52-Week) Safety Trial
In a 52-week, placebo-controlled, long-term safety trial, 605 patients (307 females and 298 males aged 12 years and older) with perennial allergic rhinitis were treated with Cultivate Nasal Spray 110 mcg once daily for 12 months and 201 were treated with placebo nasal spray. While most adverse reactions were similar in type and rate between the treatment groups, epistaxis occurred more frequently in patients who received Cultivate Nasal Spray (123/605, 20%) than in patients who received placebo (17/201, 8%). Epistaxis tended to be more severe in patients treated with Cultivate Nasal Spray. All 17 reports of epistaxis that occurred in patients who received placebo were of mild intensity, while 83, 39, and 1 of the total 123 epistaxis events in patients treated with Cultivate Nasal Spray were of mild, moderate, and severe intensity, respectively. No patient experienced a nasal septal perforation during this trial.
6.2 Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing use of Cultivate Nasal Spray. 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to Cultivate furoate or a combination of these factors.
Immune System Disorders
Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria.
Respiratory, Thoracic, and Mediastinal Disorders
Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness, and nasal septal perforation.
7 DRUG INTERACTIONS
Cultivate furoate is cleared by extensive first-pass metabolism mediated by CYP3A4. In a drug interaction trial of intranasal Cultivate furoate and the CYP3A4 inhibitor ketoconazole given as a 200-mg once-daily dose for 7 days, 6 of 20 subjects receiving Cultivate furoate and ketoconazole had measurable but low levels of Cultivate furoate compared with 1 of 20 receiving Cultivate furoate and placebo. Based on this trial and the low systemic exposure, there was a 5% reduction in 24-hour serum cortisol levels with ketoconazole compared with placebo. The data from this trial should be carefully interpreted because the trial was conducted with ketoconazole 200 mg once daily rather than 400 mg, which is the maximum recommended dosage. Therefore, caution is required with the coadministration of Cultivate Nasal Spray and ketoconazole or other potent CYP3A4 inhibitors.
Based on data with another glucocorticoid, Cultivate propionate, metabolized by CYP3A4, coadministration of Cultivate Nasal Spray with the potent CYP3A4 inhibitor ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to Cultivate furoate. High exposure to corticosteroids increases the potential for systemic side effects, such as cortisol suppression.
Enzyme induction and inhibition data suggest that Cultivate furoate is unlikely to significantly alter the cytochrome P450-mediated metabolism of other compounds at clinically relevant intranasal dosages.
Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Cultivate furoate.
- Coadministration of ritonavir is not recommended. (5.6, 7)
- Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole. (5.6, 7)
8 USE IN SPECIFIC POPULATIONS
Hepatic impairment may increase exposure to Cultivate furoate. Use with caution in patients with moderate or severe hepatic impairment.
8.1 Pregnancy
Teratogenic Effects
Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
There were no teratogenic effects in rats and rabbits at inhaled Cultivate furoate dosages of up to 91 and 8 mcg/kg/day, respectively (approximately 7 and 1 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). There was also no effect on pre- or post-natal development in rats treated with up to 27 mcg/kg/day by inhalation during gestation and lactation (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis).
There are no adequate and well-controlled studies in pregnant women. Cultivate Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
8.3 Nursing Mothers
It is not known whether Cultivate furoate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Since there are no data from controlled trials on the use of intranasal Cultivate furoate by nursing mothers, caution should be exercised when Cultivate Nasal Spray is administered to a nursing woman.
8.4 Pediatric Use
Controlled clinical trials with Cultivate Nasal Spray included 1,224 patients aged 2 to 11 years and 344 adolescent patients aged 12 to 17 years . The safety and effectiveness of Cultivate Nasal Spray in children younger than 2 years have not been established.
Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Cultivate Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Cultivate Nasal Spray, each patient’s dose should be titrated to the lowest dosage that effectively controls his/her symptoms.
A randomized, double-blind, parallel-group, multicenter, 1-year placebo-controlled clinical growth trial evaluated the effect of 110 mcg of Cultivate Nasal Spray once daily on growth velocity in 474 prepubescent children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years) with stadiometry. Mean growth velocity over the 52-week treatment period was lower in the patients receiving Cultivate Nasal Spray (5.19 cm/year compared with placebo (5.46 cm/year). The mean treatment difference was -0.27 cm/year (95% CI: -0.48 to -0.06) .
8.5 Geriatric Use
Clinical studies of Cultivate Nasal Spray did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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 of concomitant disease or other drug therapy.
8.6 Hepatic Impairment
Use Cultivate Nasal Spray with caution in patients with moderate or severe hepatic impairment .
8.7 Renal Impairment
No dosage adjustment is required in patients with renal impairment .
10 OVERDOSAGE
Chronic overdosage may result in signs/symptoms of hypercorticism . There are no data on the effects of acute or chronic overdosage with Cultivate Nasal Spray. Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical trials (with dosages of up to 440 mcg/day for 2 weeks [4 times the maximum recommended daily dose]), overdose is unlikely to require any therapy other than observation.
Intranasal administration of up to 2,640 mcg/day (24 times the recommended adult dose) of Cultivate furoate was administered to healthy human volunteers for 3 days. Single- and repeat-dose trials with orally inhaled Cultivate furoate doses of 50 to 4,000 mcg have shown decreased mean serum cortisol at doses of 500 mcg or higher. The oral median lethal dose in mice and rats was greater than 2,000 mg/kg (approximately 74,000 and 147,000 times, respectively, the maximum recommended daily intranasal dose in adults and 52,000 and 105,000 times, respectively, the maximum recommended daily intranasal dose in children, on a mcg/m2 basis).
Acute overdosage with the intranasal dosage form is unlikely since 1 bottle of Cultivate Nasal Spray contains approximately 3 mg of Cultivate furoate, and the bioavailability of Cultivate furoate is less than 1% for 2.64 mg/day given intranasally and 1% for 2 mg/day given as an oral solution.
11 DESCRIPTION
Cultivate furoate, the active component of Cultivate Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:
- With the cap on, shake the device well (Figure 1). This is important to make the medicine a liquid that will spray.
- Take the cap off by squeezing the finger grips and pulling it straight off (Figure 2).
- Hold the device with the nozzle pointing up and away from you. Place your thumb or fingers on the button. Press the button all the way in 6 times or until a fine mist sprays from the nozzle (Figure 3). Your Cultivate Nasal Spray is now ready to use.
How to use your Cultivate Nasal Spray
Follow the instructions below. If you have any questions, ask your healthcare provider or pharmacist.
Before taking a dose of Cultivate Nasal Spray, gently blow your nose to clear your nostrils. Shake the bottle well. Then do these 3 simple steps: Place, Press, Repeat.
1. PLACE
Tilt your head forward a little bit. Hold the device upright. PLACE the nozzle in one of your nostrils (Figure 4).
Point the end of the nozzle toward the side of your nose, away from the center of your nose (septum). This helps get the medicine to the right part of your nose.
2. PRESS
PRESS the button all the way in 1 time to spray the medicine in your nose while you are breathing in (Figure 5).
Do not get any spray in your eyes. If you do, rinse your eyes well with water.
Take the nozzle out of your nose. Breathe out through your mouth (Figure 6).
3. REPEAT
To deliver the medicine to the other nostril, REPEAT Steps 1 and 2 in the other nostril (Figure 7).
If your healthcare provider has told you to take 2 sprays in each nostril, do Steps 1-3 again.
Put the cap back on the device after you have finished taking your dose.
How to clean your Cultivate Nasal Spray
After each use: wipe the nozzle with a clean, dry tissue (Figure 8). Never try to clean the nozzle with a pin or anything sharp because this will damage the nozzle. Do not use water to clean the nozzle.
Once a week: clean the inside of the cap with a clean, dry tissue (Figure 9). This will help keep the nozzle from getting blocked.
How to store your Cultivate Nasal Spray
- Keep your Cultivate Nasal Spray and all medicines out of the reach of children.
- Store between 59°F and 86°F (15°C and 30°C). Do not refrigerate or freeze.
- Store with the cap on.
- Store in an upright position.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Cultivate is a registered trademark of the GSK group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2016 the GSK group of companies. All rights reserved.
July 2016
VRM:12PIL
PIL parts figure PIL Figure 1 PIL Figure 2 PIL Figure 3 PIL Figure 4 PIL Figure 5 PIL Figure 6 PIL Figure 7 PIL Figure 8 PIL Figure 9
Cultivate pharmaceutical active ingredients containing related brand and generic drugs:
Cultivate available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.