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Vaginal suppositories containing (15S)-15-methyl prostaglandin F2 alpha methyl ester were administered to 40 subjects, in an attempt to induce an early abortion. All subjects were 49 days or less from their last menstrual period. Ten subjects received a 3-mg suppository followed in 3 hours by a 1 mg suppository, ten subjects received the 1-mg suppository followed in 3 hours by a 3-mg suppository, and twenty subjects received the 3-mg suppository followed in 1 hour by the 1-mg suppository. Twenty-four subjects (60%) had a successful termination of their pregnancy using the two vaginal prostaglandin suppository regimen. All subjects who aborted had 10 percent or less of their pretreatment levels of beta-hCG 7 to 22 days after therapy. Sixteen subjects (40%) did not abort. One of the subjects who failed treatment refused the second suppository due to gastrointestinal side effects and uterine cramping following the insertion of the 1-mg suppository. A second subject had an incomplete abortion and developed mild endometritis. Sixteen subjects reported side effects which included nausea, emesis, diarrhea, uterine cramping requiring analgesia, restlessness, shakiness, and dizziness. The addition of the second vaginal suppository containing this particular prostaglandin analogue did not significantly increase the overall abortifacient activity of this method.
Vaginal suppositories frequently used in gynaecological therapy were studied. Several antibacterial pharmacons are used for the topical treatment of vaginitis of various origins. In view of the fact that the liberation of the given active substance and the subsequent therapeutic effect may be improved or inhibited by the vehicle, our aim was to find the optimal suppository base for vaginal suppositories containing sulfadimidine, chloramphenicol and gentamicin sulfate by means of in vitro experiments. On the basis of breaking hardness, disintegration time and spreading properties the French Suppocire NA product, and compositions of macrogols with lower molecular weight proved to be the best lipophilic and hydrophilic bases, respectively. Among the lipophilic bases the in vitro drug liberation of Suppocire NA was significantly better (P < 0.05) than the other lipophilic bases. This vehicle is recommended for the topical treatment of vaginitis, as these suppositories have the further advantage that they can easily be produced on a magistral, galenical or industrial scale as well.
Vaginal suppositories containing 15 methyl prostaglandin F2 alpha methyl ester in a high-melt base were administered to 60 women desiring early pregnancy interruption who were no more than 56 days' (eight weeks) pregnant as calculated from the first day of the last regular menstrual period (LMP). The purpose of this study was to evaluate the safety, efficacy, and patient acceptability of this mode of noninvasive early abortion. Some factors evaluated during the study included the time interval from insertion of the suppository to the onset of cramping and bleeding. Also measured were immediate and delayed blood loss, nausea, vomiting, and diarrhea. Of the 60 patients entered into the study, 55 procedures have been judged as successful by the prospective criteria set forth in the protocol. There were no deaths or serious complications. Four patients required hospitalization and follow-up dilatation and curettage (D&C). One patient withdrew from the study after receiving a suppository and subsequently delivered a preterm infant.
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The purpose of this investigation was to compare quality parameters, including product appearance, content uniformity, pH, weight uniformity, microbial limit testing and preservative effectiveness testing on extemporaneously compounded progesterone vaginal suppositories obtained from 10 randomly chosen compounding pharmacies (90 suppositories each) across the United States, to the Food and Drug Administration (FDA) approved prescription progesterone gel product (Prochieve/Crinone) which is manufactured in a cGMP regulated facility. The content uniformity and pH were determined using qualified methods. The microbial limits testing and preservative effectiveness testing were conducted according to compendial methods. Only one pharmacy provided suppositories that were all within the potency limits required for the prescription progesterone gel product. The other pharmacies provided at least some suppositories where progesterone content was either subpotent or superpotent for progesterone. The pH of most of the compounded suppository products was in the range of 4.22 to 7.68 with a median of 6.30 (normal vaginal pH is <5), whereas the gel product was 2.80. For compounded product from one of the pharmacies, microbial limits testing indicated CDC group IVC-2 and Comamonas acidovorans were detected. This data indicates that pharmacy compounded delivery systems for progesterone should be used with caution.
Observations made with Betadine vaginal suppository in the treatment of 60 women suffering from colpitis have been discussed. The results of microbiological examinations of vaginal discharge sampled before 1 week and 4 weeks after the onset of therapy were compared. The effectiveness, tolerance of therapy, and the subjective opinion of the treated women were analysed. According to the results of the examinations in response to Betadine vaginal suppository the positivity of vaginal discharge for Candida decreased from 16 to 3 cases, for Trichomonas from 8 to 1 case, for aerobic bacteria from 16 to 7 cases, and the occurrence of mixed infections from 20 to 2 cases. Subjective complaints, burning, stinging sensation were rapidly moderated. In 52 of the 60 women discharge ceased, in another 4 cases it significantly decreased. In 51 cases burning sensation in the vagina ceased, and in 5 women it significantly decreased. Recurrence was not observed when a control examination was done after 1 month. The women tolerated Betadine vaginal suppository well and found it effective and easily applicable. At the beginning of treatment burning sensation was aggravated in 3 cases. These patients refused to further participate in the examination and received systemic treatment. Due to its broad bactericidal, fungicidal, protozoicide action and its good tolerability Betadine suppository was found to be useful for the local treatment of colpitis.
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Vaginal suppositories of Adriamycin (ADM, 5 mg), for reducing the capacity for repair from sublethal damage of X-ray-irradiated cells, were prepared using Wipepsol S-55 as the vehicle, and were intravaginally administered to patients with advanced uterine cervical cancer, and their pharmacokinetics and clinical effects were studied. The ADM concentration in the uterine cervical cancer tissues indicated high levels (17 to 566 micrograms/g), and migration into the cardinal ligament and regional lymph nodes was noted. However, little ADM was detected in serum (0 to 0.14 micrograms/g), probably because of its molecular weight and excellent tissue absorbance, and no side effects, such as cardiotoxicity and myelosuppression due to consecutive administration were detected. Histologically, the effect obtained when administered alone was limited, administration in combination with radiotherapy being more effective. Accordingly, radiotherapy of advanced uterine cervical cancer with concomitant administration of ADM vaginal suppositories seems to bring about a more powerful antitumoral effect with fewer systemic side effects.
One-hundred subjects received vaginal suppositories containing prostaglandin analogues in order to terminate their pregnancies of 49 days gestation or less. This non-surgical method was successful in 61 subjects, failed in 35 subjects and four subjects were lost to follow-up. Success of prostaglandin therapy cannot be predicted using pretreatment clinical parameters, pretreatment serum beta-hCG levels, or the passage of tissue from the vagina based upon history obtained from the subject. The passage of tissue histologically identified as of fetal origin is a definitive way to determine the success of pregnancy termination but the passage of tissue obtained by history is not. Of the 61 subjects in whom the prostaglandin suppositories were a success, 56 (92%) had a beta-hCG level day 7 +/- 2 following treatment which was 15% or less than the pretreatment value and 5 had beta-hCG levels which were more than 15% of the pretreatment value. All subjects with beta-hCG levels 5 to 9 days after the abortion that were less than 15% of the pretreatment concentrations had a successful termination. Of 35 subjects in whom the prostaglandin suppositories were unsuccessful, 26 had a beta-hCC level 7 +/- 2 days following treatment which was greater than the pretreatment level and 9 had beta-hCG levels less than the pretreatment value. The results of this study indicate that when prostaglandin vaginal suppositories are used to terminate early gestations, if there is no decline in beta-hCG levels 7 +/- 2 days following treatment, the pregnancy should be terminated by another method.
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OBJECTIVE: This study was undertaken to investigate whether amphotericin B vaginal suppositories would be effective in the treatment of non- albicans Candida vaginitis in women who failed conventional therapy. STUDY DESIGN: Thirty-two patients were identified with non- albicans Candida vaginitis. These patients were treated with conventional antifungal agents. Ten patients had persistence of the non- albicans Candida infection after treatment. Amphotericin B 50-mg vaginal suppositories were given nightly for 14 days to this subgroup of treatment failures. RESULTS: Of 10 women, 8 (80%) who were treated with amphotericin B vaginally initially showed no further infection. One of the treatment successes had 2 recurrences and responded to a second course of amphotericin B but failed a third course. If this patient is considered a treatment failure, then amphotericin B vaginal suppositories were successful in 70% of patients. The medication was well tolerated and local side effects were minimal. CONCLUSION: Amphotericin B vaginal suppositories are a viable treatment option for refractory vaginitis caused by non- albicans Candida .
Comparison of 1 mg Gemeprost-Vaginal Suppositories Serial Application versus Sulproston i.v.: Three different regimens for the termination of second and third trimester pregnancies by the use of prostaglandins (PG) were compared in a retrospective analysis. In group A (n = 16) terminations were attempted by continuous i.v. Infusion of Sulproston 9 hours after administration of a 3 mg-PGE2-vaginal tablet overnight. In group B (n = 22), i.v. Sulproston was started 2 hours after priming with 1 mg Gemeprost-vaginal suppositories. The outcome of these two regimens was compared with that of repeated administration of 1 mg Gemeprost-vaginal suppositories at 6-hourly intervals (group C, n = 25). In each group. If uterine contractions failed to appear after one day, the treatment was discontinued for a sleep rest over night and then resumed. Genetic disorders or fetal malformations were the most frequent reasons for termination. Patients with intrauterine fetal demise, rupture of the membranes, preterm labour or a ripe cervix (Bishop Score > 3) were excluded. Median time intervals from induction to abortion were 33 hours in group A and 23 hours in each Group B and C. The rate of fetal expulsions within 12, 24 and 36 hours in groups B and C were similar. Women of parity > or = 1 showed significantly shorter intervals than nulliparae in groups A and C. Only one woman (in group A) failed to expel after induction, in four other cases (in groups A and B) complications (local thrombophlebitis, bronchospasm) were noted. The serial administration of 1 mg Gemeprost-vaginal suppositories at 5-hourly intervals showed fewer side effects and seems to be as efficient as sulproston i.v. after cervical ripening.
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AIM: The aim of this paper was to estimate the effectiveness of the contemporary oral administration of Lactobacilllus paracasei subsp paracasei F19 in association with vaginal suppositories containing Lactobacilllus acidofilus in the treatment of bacterial vaginosis and in the prevention of recurrent vaginitis. METHODS: We have recruited 60 women in good health, aged between 18 and 40 years with suspect or confirmed diagnosis of bacterial vaginosis. The women were randomized in 2 groups: Group A treated with vaginal suppositories containing Lactobacillus acidofilus (Calagin, SIFFRA, Florence); Group B treated with the same vaginal suppositories + probiotic containing Lactobacilllus paracasei subsp paracasei F 19 for oral administration (Gene-filus F19, SIFFRA, Florence). The patients were examined at the end of therapy (3 months) and then after 3 months from the end of treatment. RESULTS: In both groups at end of therapy there was a significant reduction of vaginal pH, an improvement of sniff test and of the subjective symptomatology after 3 months of treatment which still decreased during follow-up (3 months). In Group B there was a meaningful reduction of vaginal pH and of sniff test at the end of therapy and a maintenance of positive effect also after 3 months. CONCLUSIONS: The results obtained in this study show that the therapy with vaginal Lactobacillus in the treatment of bacterial vaginosis is successful. The association of oral administration is useful to balance the vaginal environment with the intestinal microflora with improvement of long-term results. The use of probiotics was determinant in the treatment of a pathology like bacterial vaginosis and as an alternative to the conventional local antibiotic therapies.
Serum progesterone levels from a vaginal tablet formulation and six different vaginal suppository formulations, each containing 25 mg of progesterone, were evaluated in mongrel dogs. Bioavailabilities relative to an intravenous dose of progesterone were calculated. The vaginal tablet was found to have a significantly higher bioavailability compared with the vaginal suppositories.
Vaginal suppositories containing the 16-16 dimethyl trans delta 2 PGE1 methyl ester (ONO 802) were used for the induction of abortion in early pregnancy, and this non-surgical technique was compared with suction termination performed under local anaesthesia or general anaesthesia. Ninety patients were recruited to the study and divided equally between the three groups. Complete abortion was induced in 87 per cent of the patients treated with ONO 802 suppositories, which compared favourably with 87 and 100 per cent for the patients who had suction terminations under local anaesthesia and general anaesthesia respectively. The vaginal suppositories induced uterine bleeding in all patients and the mean time of onset of lower abdominal pain was 2 hours 55 minutes. The average numbers of episodes of vomiting and diarrhoea for patients given ONO 802 suppositories were 0.9 and 0.7 respectively. Menstrual blood loss was measured objectively in all groups and no significant differences between the three methods could be found. In selected cases, ONO 802 vaginal suppositories would seem to be safe and reasonably effective for the termination of early pregnancy.